FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1223247
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03706
- 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
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS NOTED ABRASION THE OUTER INSULATION AT 48.5 CM FROM CONNECTOR PIN. BOTH THE IS-1 PROXIMAL CABLE WIRES AND ONE OF THE RV CABLE WIRE WERE MELTED. THE ETFE INSULATION ON THE CABLES WAS ALSO ABRADED AND MELTED. THE LEAD ABRASIONS ARE CONSISTENT WITH THAT PRODUCED BY FRICTION WITH ANOTHER DEVICE.
Description of Event or Problem · 1
PATIENT RECEIVED EXCESSIVE INAPPROPRIATE THERAPIES, DUE TO NOISE. CLAVICULAR CRUSH WAS SUSPECTED. AS SUCH, THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |