FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242827
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06162
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 11, 2011
- 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. THE REPORTED INSULATION ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND SEVERAL INSIDE-OUT ABRASIONS. THE RV AND SENSING CABLES WERE EXPOSED IN THESE AREAS. THE PFTE CABLE INSULATIONS AT THESE AREAS WERE NORMAL. NORMAL COIL CONTINUITY AND INSULATION RESISTANCE WERE MEASURED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN X-RAY REVEALED THE INNER COIL OUTSIDE OF THE INSULATION. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |