FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1223634
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03578
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 23, 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
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION FOUND INSULATION ABRASION AT 28.5 CM FROM THE CONNECTOR PIN. THE ETFE INSULATION OF THE RV CABLE WAS DAMAGED AND A BURN MARK WAS NOTED. THE DAMAGE FOUND IS CONSISTENT WITH INSULATION ABRASION CAUSED BY FRICTION TO THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT POSSIBLE CIRCUIT DAMAGE ON THE DEVICE WAS ALERTED. THE DEVICE AND LEAD WERE EXPLANTED. LEAD DAMAGE WAS OBSERVED DURING EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |