FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223545
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03609
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 6, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE RETURNED LEAD WAS CUT AT 24.5 CM FROM THE CONNECTOR. THE DISTAL END OF THE LEAD WAS NOT RETURNED. ANALYSIS FOUND OUTER INSULATION ABRASION AT 11.6 CM FROM THE CONNECTOR. THE IS-1 PROXIMAL CABLES WERE SLIGHTLY EXPOSED IN THIS AREA; HOWEVER, THE ETFE INSULATION WAS NOT DAMAGED. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE INSULATION ABRASION IS CONSISTENT WITH FRICTION TO THE CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE ON THE LEAD. THE LEAD WAS EXPLANTED.
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 | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |