FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4152050
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-06776
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- October 24, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOOD FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELL. THE PT PRESENTED TO THE CLINIC FOR FOLLOW UP. THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND OVERSENSING. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27613 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE, DTB | DTB | ST. JUDE MEDICAL, INC. CRMD | 2088TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |