FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1223443
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03647
- 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
- Product Problem
- Yes
- 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 THE PROXIMAL INSULATION WAS FOUND ABRADED DUE TO FRICTION WITH THE ICD CAN. THE PROXIMAL INSULATION WAS ALSO ABRADED AND CRUSHED. THE DISTAL INSULATION WAS DAMAGED AT 30.5 CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH. NO DEFECTS IN MATERIALS OR WORKMANSHIP WERE NOTED. RELIABILITY LABORATORY TECHNICIAN; ST JUDE MEDICAL CRMD RELIABILITY LABORAATORY NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. EVENT (FAILURE) 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 ST ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |