FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1895562
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04271
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 12, 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. ANALYSIS FOUND THAT THE OUTER INSULATION WAS ABRADED BETWEEN 12.7 CM AND 13 CM, EXPOSING THE BLUE CABLES. HOWEVER, THE INNER INSULATION AND THE INSULATION OF THE BLUE CABLES WERE FOUND INTACT. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE LEAD IMPEDANCE, PACING COIL RESISTANCE AND HIGH VOLTAGE INTERGRITY COULD NOT BE MEASURED, AS THE LEAD WAS CUT IN THE FIELD AND THE EXPLANT TOOL COULD NOT BE REMOVED.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO NOISE OBSERVED ON THE STORED EGM.
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 | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |