FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1896008
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04376
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 29, 2010
- 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 Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER: NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO THE PATIENT NOTIFIER GOING OFF. UPON INTERROGATION LOW IMPEDANCE WAS OBSERVED. INSULATION ANOMALY WAS SUSPECTED. THE PHYSICIAN OPTED NOT TO EXTRACT THE LEAD DUE TO THE PATIENT'S REQUEST. THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD.
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 | 1590/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |