FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073598
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02482
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 9, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND THAT THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. ABRASION MARKS WERE OBSERVED ON THE OUTER INSULATION AT 9, 10, AND 11 CM FROM THE LEAD TIP. THE LEAD WAS POSITIONED IN AN AREA PASSING THE TRICUSPID VALVE. THE DAMAGE IS BELIEVED TO BE CAUSED OVER TIME BY THE CLOSING OF THE VALVE. DRIED BODY FLUID INSIDE THE HEADER, THE INNER INSULATION AND COIL PREVENTED PROPER DISTAL COIL ROTATION, RESULTING IN AN OVERTORQUE CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AS A RESULT OF AN INSULATION ANOMALY.
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 | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |