FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984409
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00477
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 28, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED IN THREE PARTS. THE CONNECTOR BOOT WAS DAMAGED AND THE SENSING COIL WAS FRACTURED DUE TO FATIGUE RESULTING IN AN OPEN CIRCUIT NEAR THE CRIMP SLEEVE BY THE CONNECTOR RING. ALL OTHER DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO AN INSULATION ANOMALY FOUND ON THE IS1 CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88304 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |