FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4202310
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04931
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- March 6, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT, THE ATRIAL LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28393 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, CRMD | 2088TC/496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |