FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4231380
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18171
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- September 25, 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
- OH, US
- Reporter Occupation
- NURSE
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 VIA A REMOTE TRANSMISSION, THE RIGHT ATRIAL LEAD EXHIBITED UNDERSENSING. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2014 AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714548 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |