FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1895565
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04280
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- July 30, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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 INSULATION ABRASION DAMAGE WAS FOUND AT 13.3 CM FROM THE CONNECTOR PIN. THE ETFE COATING ON ONE OF THE PROXIMAL CABLE WAS ALSO ABRADED IN THE SAME AREA, EXPOSING THE PROXIMAL CABLE. THIS WOULD CAUSE THE REPORTED OVERSENSING. THE ABRASION IS CONSISTENT WITH THAT PRODUCED BY FRICTION WITH ANOTHER DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED TO THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1572/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | (B)(4) |