FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2983926
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01453
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- December 14, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE, IMPEDANCE GREATER THAN 2000 OHMS AND WAS FRACTURED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85632 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |