FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984541
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00472
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 29, 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 Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXTERNAL INSULATION ABRASION WAS FOUND AT 14.6 - 14.9CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH PACING THRESHOLD AND AN INSULATION ANOMALY WERE OBSERVED DUE TO TWIDDLER'S SYNDROME. THE LEAD WAS EXPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88405 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |