FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984383
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00425
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 28, 2012
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A FRACTURE OF THE CONDUCTOR WAS FOUND AT 3.1CM FROM THE CONNECTOR PIN CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF HIGH HV LEAD IMPEDANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH HV IMPEDANCE WAS OBSERVED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87695 | 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 |