FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4231455
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18224
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- August 6, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A POST OPERATIVE DEVICE CHECK AND UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED UNDER SENSING, UNACCEPTABLE THRESHOLD AND LOSS OF CAPTURE IN UNIPOLAR CONFIGURATION. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713553 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |