FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 3926243
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15566
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 3, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 THE ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND SENSING. THE DEVICE WAS REPROGRAMMED TO VVIR, DISABLING ATRIAL THERAPY. PATIENT WAS SEEN ON (B)(6) 2014 AND FELT FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404354 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1488TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |