FDA Adverse Event
Summary report: N
TENDRIL STS
MDR report key: 3951261
·
Received July 22, 2014
Report
- Report Number
- 2017865-2014-07325
- Date Received
- July 22, 2014
- Date of Event
- August 2, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC, CRMD
- Product Code
- DTS
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
NEW INFORMATION (B)(6) 2014 INDICATES THE LEAD CONTINUES TO EXHIBIT NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE WITH OVERSENSING. THE LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428046 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE, DTS | DTS | ST. JUDE MEDICAL, INC, CRMD | 2088TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |