FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223523
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03612
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 COMPLAINT WAS VERIFIED. THE DISTAL PORTION OF THE LEAD WAS RETURNED. THE OUTER AND BLUE CABLE INSULATION ON THE SENSING CABLES WERE DAMAGED AT 46 CM FROM THE LEAD TIP AS A RESULT OF FRICTION TO THE ICD CAN. THE METAL WIRES OF THE SENSING CABLE WERE EXPOSED, WHICH CAN LEAD TO OVERSENSING THERAPY. THE RETURNED LEAD PORTION EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS..
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. NOISE WAS OBSERVED ON THE IEGMS. THE LEAD WAS REPLACED.
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 | Required Intervention |