FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984364
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00353
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 3, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE LEAD WAS NOT REMOVED DURING ICD REVISION, THE LEAD REMAINS IMPLANTED AND IS WORKING WELL. NO FURTHER REVISION ARE CURRENTLY PLANNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE DEVICE CHANGEOUT, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. THE PATIENT WAS ASYMPTOMATIC. ELECTRICAL FUNCTION WAS TESTED AND NO ANOMALIES WERE DETECTED. LEAD WILL BE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88027 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1591/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |