FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223267
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03701
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- 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 ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. THE INSULATION WAS ABRADED AND THE PROXIMAL CABLE WAS EXPOSED DUE TO FRICTION WITH THE ICD CAN. RELIABILITY LABORATORY TECHNICIAN; ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
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 | 1582/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |