FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2851610
·
Received November 29, 2012
Report
- Report Number
- 2017865-2012-10507
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- September 21, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 54.1CM WAS RETURNED FOR ANALYSIS. INTERNAL INSULATION ABRASION WAS FOUND AT 7.3CM TO 9.4CM AND AT 8.5CM TO 9.8CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. THE CAUSE OF THE REPORTED CAPTURE ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NO CAPTURE AND EXTERNALIZED CONDUCTORS WERE OBSERVED. LEAD WAS EXPLANTED AND REPLACED.
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 | 1591/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |