FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2983756
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01510
- Event Type
- Malfunction
- 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
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING SYNCOPAL EPISODES. THE PATIENT HAD AN INTRINSIC RATE BETWEEN 27 TO 50 BEATS PER MINUTE. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND NOISE. DUE TO THE PATIENT'S CONDITION SURGERY WAS NOT POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87606 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |