FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1483744
·
Received September 25, 2009
Report
- Report Number
- 2017865-2009-03266
- Event Type
- Death
- Date Received
- September 25, 2009
- Date of Event
- May 26, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED, 28 CM IN LENGTH. VISUAL INSPECTION FOUND INSULATION ABRASION AT 21.1CM FROM CONNECTOR PIN, AND THE RV ETFE COATING WAS ABRADED THROUGH. SEM PHOTO SHOWED THE FILARS OF THE RV CABLE WERE FRACTURED. THE ABRASION NOTED WAS CONSISTENT WITH THAT CAUSED BY FRICTION TO THE ICD CAN.
Description of Event or Problem · 1
THE PATIENT EXPIRED. REVIEW OF THE SEGMS SHOWED T-WAVE OVERSENSING IN 2009. THE DEVICE CHARGED AND DELIVERED THERAPY. THE DEVICE MAKES A SECOND ATTEMPT TO CHARGE; IT WAS ABORTED. IT IS BELIEVED THAT THE LEAD ARCED TO THE ICD AT THIS TIME.
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 | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death | V-232 54701 |