FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4121577
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-07694
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- September 17, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS SEEN ON THE VENTRICULAR CHANNEL LEADING TO VENTRICULAR NOISE REVERSION EPISODES. PATIENT IS PACER DEPENDENT. SENSING CONFIGURATION WAS CHANGED TO UNIPOLAR AND SENSITIVITY WAS REDUCED. LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32294 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC. CRMD | 2088TC/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |