FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 6133863
·
Received November 29, 2016
Report
- Report Number
- 2017865-2016-07411
- Event Type
- Malfunction
- Date Received
- November 29, 2016
- Date of Event
- October 8, 2016
- Report Date
- October 13, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCING POCKET STIMULATION PRESENTED TO CLINIC FOR FOLLOW UP. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED LOW IMPEDANCE AND NOISE. THE LEAD WAS REPROGRAMMED. THE PATIENT WOULD CONTINUED TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784393 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/52 | A000002232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |