FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050864
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01806
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- December 5, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- 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.
Description of Event or Problem · 1
PATIENT PRESENTED FOR FOLLOW-UP AND UPON INTERROGATION, SEVERAL NON-SUSTAINED EPISODES WERE DETECTED IN THE VENTRICULAR FIBRILLATION ZONE OVER THE PAST SIX MONTHS. STORED EGMS REVEALED THAT THE EPISODES WERE CAUSED BY NOISE. WHILE PERFORMING A HIGH VOLTAGE LEAD INTEGRITY CHECK, IT WAS NOTED THAT THE IMPEDANCE WAS OUT OF RANGE AND THE TEST WAS UNABLE TO BE COMPLETED. THE PATIENT WAS THEN ADMITTED AND MONITORED. AT EXPLANT, AN INSULATION BREACH WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |