FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 2905326
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00654
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 19, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 PATIENT COMPLAINED OF PALPITATIONS. A HOLTER MONITOR REVEALED 6 EVENTS IN 24 HRS WHERE THERE WAS FAILURE TO OUTPUT ON THE VENTRICULAR CHANNEL. ON (B)(6) A CHEST X-RAY REVEALED NO ISSUES. THE PHYSICIAN THEN BELIEVED THAT THE LOSS OF OUTPUT WAS INSTEAD NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10975 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |