FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984177
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00423
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 13, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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 LOW HIGH VOLTAGE IMPEDANCE WAS OBSERVED AFTER IMPLANT OF LEFT VENTRICULAR ASSIST DEVICE. DECREASED PACING LEAD IMPEDANCE AND INCREASED CAPTURE THRESHOLD WERE NOTED. THE SVC COIL WAS TURNED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87333 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |