FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2890011
·
Received December 28, 2012
Report
- Report Number
- 2017865-2012-10741
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- October 26, 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
- RI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT AN ALERT WAS DELIVERED FOR HIGH, HV LEAD IMPEDANCE. THE PHYSICIAN REPROGRAMMED THE UPPER ALERT LIMIT AND ROUTINE FOLLOW-UP WILL CONTINUE.
Description of Event or Problem · 1
PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. THE ELECTRICAL FUNCTION OF THE LEAD WAS TESTED AND OBSERVED AND NO ELECTRICAL ANOMALIES WERE NOTED. BASED ON THE REVIEW OF THE FLUOROSCOPY, EXTERNALIZED CONDUCTORS WERE NOTED. LEAD WILL BE MONITORED.
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 | 55 YR |