FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223715
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03539
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS NOTED THE OUTER INSULATION ABRADED THROUGH INTERNALLY, EXPOSING THE RING CABLES. THE SVC SHOCK COIL WAS FOUND TO HAVE ALL THREE SHOCK COIL FILARS FRACTURED AT THE PROXIMAL SHOCK COIL TERMINAL RING. SEM ANALYSIS OF THE SVC SHOCK COIL FRACTURED FILAR SURFACE SHOWS CONTINUAL RUBBING TOGETHER OF THE FRACTURED SURFACE, INDICATING A LIKELY FRACTURE, DUE TO CYCLIC MOTION OVEER A LONG PERIOD OF TIME. CROSS SECTION OF THE RING CABLE AREA CONFIRMED INTERNAL ABRASION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED, DUE TO A FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |