FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984483
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00461
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 18, 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
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED LEAD FRACTURE WAS CONFIRMED. THE IS-1 PACE/ SENSE OUTER COIL WAS FRACTURED DUE TO FATIGUE AT THE DISTAL END OF THE CONNECTOR ASSEMBLY. THIS FRACTURE IS CONSISTENT WITH THE REPORTED FIELD OBSERVATIONS OF NOISE AND INAPPROPRIATE THERAPY.
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 INAPPROPRIATE THERAPY DUE TO NOISE WAS OBSERVED. FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88572 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |