FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 6051930
·
Received October 24, 2016
Report
- Report Number
- 2017865-2016-06739
- Event Type
- Malfunction
- Date Received
- October 24, 2016
- Date of Event
- August 18, 2016
- Report Date
- August 18, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE ATRIAL LEAD WAS CONNECTED TO THE DEVICE A LOSS OF CAPTURE AND SENSING WAS NOTED. THE LEAD ALSO EXHIBITED NOISE AND LOW IMPEDANCE MEASUREMENTS. THE ISSUE PERSISTED AND THE LEAD WAS NO LONGER USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION POST SURGERY AND WOULD CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701503 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/46 | A000025319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |