MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/28/2018
Start Date:July 2008
End Date:December 2015

Use our guide to learn which trials are right for you!

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

The primary purpose of this study is to assess the long term reliability of the Medtronic
Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of
approval of nEw3 devices. Patients will be followed for 5 years after implant. This study
utilizes data collected from the System Longevity Study (SLS).

The rate of device malfunctions will be determined and a comparison to historical controls
will be done.

Inclusion Criteria:

- Subjects or appropriate legal guardians provide written informed consent and/or
authorization for access to and use of health information, as required by an
institution's IRB/MEC/REB.

AND one of the following must also apply:

- Subjects indicated for implant or within six months post-implant of a Medtronic
market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The
Medtronic lead must be used for pacing, sensing or defibrillation application.

- Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy
product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is
market-released 3) complete implant and follow-up data, including product-related
adverse events are available and 4) subject of appropriate legal guardian authorizes
release of subject study data to SLS

- Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic
CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to
retrospectively collect data for post approval requirements.

Exclusion Criteria:

- Subjects who are, or will be inaccessible for follow-up at a SLS center

- Subjects with exclusion criteria required by local law (EMEA only)

- Subjects receiving an implant of a Medtronic device at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant

- Subjects implanted with a Medtronic device whose predetermined enrollment limit for
that specific product has been exceeded
We found this trial at
111
sites
1866
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from 98109
Evansville, IN
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2041
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Akron, OH
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2283
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Albany, GA
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1184
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Albuquerque, NM
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1933
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Alexandria, LA
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1431
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Anchorage, AK
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2178
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Atlanta, GA
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1775
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from 98109
Austin, TX
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863
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from 98109
Bakersfield, CA
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2035
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from 98109
Baton Rouge, LA
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2079
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Birmingham, AL
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2543
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Bradenton, FL
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2399
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Browns Mills, NJ
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2325
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Burlington, VT
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Charleston, South Carolina 29412
2424
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Charleston, SC
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2083
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Chattanooga, TN
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2436
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Chesapeake, VA
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1072
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Chula Vista, CA
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1967
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Cincinnati, OH
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2512
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from 98109
Clearwater, FL
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2020
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from 98109
Cleveland, OH
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Colorado Springs, Colorado 80910
1070
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Colorado Springs, CO
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1614
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from 98109
Columbia, MO
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2321
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Columbia, SC
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2207
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Columbus, GA
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2004
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from 98109
Columbus, OH
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1385
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from 98109
Coon Rapids, MN
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2073
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Covington, LA
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1682
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Dallas, TX
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1020
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Denver, CO
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1463
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Des Moines, IA
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971
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Downey, CA
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2341
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Durham, NC
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702
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East Palo Alto, CA
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1966
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Edgewood, KY
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2076
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Erie, PA
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2313
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Fairfax, VA
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1172
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Fargo, ND
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2372
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Florence, SC
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1660
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from 98109
Fort Worth, TX
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2418
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from 98109
Garden City, NY
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1877
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Germantown, TN
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1129
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Gilbert, AZ
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Greensboro, North Carolina 27401
2298
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Greensboro, NC
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2207
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Henderson, NY
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1890
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Houston, TX
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Huntington, NY
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1867
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Indianapolis, IN
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2449
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Jacksonville, FL
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1806
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Jonesboro, AR
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1500
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Kansas City, KS
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1503
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Kansas City, MO
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2150
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Kingsport, TN
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1049
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La Jolla, CA
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2315
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Lancaster, PA
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1853
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Lansing, MI
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2392
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Lebanon, NH
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2005
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Lexington, KY
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5316
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Linz,
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1782
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Little Rock, AR
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979
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from 98109
Long Beach, CA
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962
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from 98109
Los Angeles, CA
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1939
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from 98109
Louisville, KY
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1616
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Madison, WI
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2164
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from 98109
Marietta, GA
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1631
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from 98109
Marquette, MI
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2603
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Melbourne, FL
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1681
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Milwaukee, WI
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1393
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from 98109
Minneapolis, MN
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1970
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Nashville, TN
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2354
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Newark, DE
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1732
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from 98109
Oak Lawn, IL
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2423
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Ocean City, NJ
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48
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Olympia, WA
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2395
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from 98109
Parlin, NJ
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1673
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from 98109
Plano, TX
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147
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Portland, OR
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2374
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from 98109
Poughkeepsie, NY
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2358
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from 98109
Raleigh, NC
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486
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from 98109
Redding, CA
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1386
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from 98109
Robbinsdale, MN
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1450
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from 98109
Rochester, MN
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2161
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from 98109
Rochester, NY
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1860
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from 98109
Saginaw, MI
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1388
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from 98109
Saint Louis Park, MN
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1400
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from 98109
Saint Paul, MN
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758
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from 98109
Salinas, CA
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2406
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from 98109
Salisbury, MD
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1790
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from 98109
San Antonio, TX
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1065
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from 98109
San Diego, CA
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635
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from 98109
Santa Rosa, CA
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2245
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from 98109
Sayre, PA
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1117
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from 98109
Scottsdale, AZ
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2319
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Silver Spring, MD
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1263
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from 98109
Sioux Falls, SD
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229
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from 98109
Spokane, WA
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26
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from 98109
Tacoma, WA
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2320
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from 98109
Takoma Park, MD
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2527
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from 98109
Tampa, FL
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1866
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from 98109
The Woodlands, TX
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1929
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from 98109
Toledo, OH
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