FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073111
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02353
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- 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
THE FIELD OBSERVATION OF LEAD INSULATION DEGRADATION WAS CONFIRMED. A VISUAL INSPECTION OF THE LEAD FOUND INSULATION ABRASION AT 7 AND 8 CM FROM THE CONNECTOR PIN. THE DAMAGE FOUND IS CONSISTENT WITH INSULATION ABRASION CAUSED BY FRICTION TO THE ICD CAN. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVERSENSING WAS OBSERVED IN THE ATRIAL AND RV CHANNELS. DURING EXPLANT, BOTH LEADS DISPLAYED INSULATION DEGRADATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |