FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1010728
·
Received March 10, 2008
Report
- Report Number
- 2017865-2008-01069
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- December 19, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND ABRASION ON THE LEAD OUTER INSULATION AND RV CABLE INSULATION AT 18.1 CM FROM THE CONNECTOR PIN. ONE OF THE RV CABLE WIRES WAS EXPOSED. THE DAMAGE FOUND IS CONSISTENT WITH THAT OF FRICTION TO THE ICD CAN.
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 | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |