FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4121557
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-07737
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- April 10, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOW LEAD IMPEDANCE, LOSS OF SENSING, AND UNACCEPTABLE THRESHOLDS. IT WAS CLINICALLY RESOLVED BY REPROGRAMMING. THE LEAD REMAINED IMPLANTED AND THE PATIENT WAS SCHEDULED FOR A FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32574 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE, DTB | DTB | ST. JUDE MEDICAL, CRMD | 2088YC/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |