FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3080131
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00973
- Event Type
- Injury
- Date Received
- April 26, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A FRACTURE OF THE INNER COIL WAS FOUND AT 11CM FROM THE CONNECTOR PIN CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF HIGH PACING IMPEDANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH PACING LEAD IMPEDANCE WAS NOTED. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182922 | 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 | 82 YR | Required Intervention |