FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2984183
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00230
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 9, 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. A PARTIAL LEAD WITH ONLY THE DISTAL PORTION WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 27.7-28.7CM AND 40.5-41.1CM FROM THE LEAD TIP. INTERNAL INSULATION ABRASION WAS FOUND AT 26.5-28.1CM AND 39.3-39.8CM FROM THE LEAD TIP.
Description of Event or Problem · 1
IT WAS REPORTED DURING SYSTEM EXPLANT, EXTERNALIZED CONDUCTORS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87334 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |