FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2083841
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-03644
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- December 8, 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
- NJ
- 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
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC WITH AN ALERT STATING POSSIBLE OUTPUT CIRCUIT DAMAGE. A CAPACITOR MAINTENANCE WAS PERFORMED, BUT THE CHARGING ABORTED. ANALYSIS OF THE DEVICE INDICATED DAMAGED OUTPUT CIRCUITRY. IT IS BELIEVED THE LEAD SHORTED CAUSING A LOW IMPEDANCE PATH THAT RESULTED IN DAMAGE TO THE OUTPUT CIRCUITRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |