FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984355
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00336
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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 LEAD WAS RETURNED IN TWO PIECES. INTERNAL INSULATION ABRASIONS WERE FOUND AT 7.7-8.3CM, 13.2-13.8CM AND 14.3 - 15.5CM FROM THE DISTAL TIP. THE ETFE COATING ON THE CONDUCTORS WAS INTACT AT ALL LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT SHORTLY AFTER IMPLANT, INCREASED PACING THRESHOLD, POOR SENSING, AND SOME T-WAVE OVERSENSING WERE OBSERVED. PATIENT RECEIVED INAPPROPRIATE THERAPY AS A RESULT. LEAD WAS CAPPED MARCH 2006 AND LATER EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87876 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |