FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2983914
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01480
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 16, 2013
- 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
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE INSULATON WAS ABRADED AT 44.3 CM TO 45.4 CM FROM THE CONNECTOR PIN. THE PROXIMAL COIL WAS EXPOSED, DUE TO FRICTION WITH ANOTHER DEVICE, WHICH COULD HAVE CAUSED THE REPORTED PROBLEM.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING A HEART RATE OF 20 BEATS PER MINUTE. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND INCREASED THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88394 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |