FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2902543
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00392
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- October 10, 2012
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE ER DUE TO RECEIVING INAPPROPRIATE SHOCKS. X-RAY NOTED THE LEAD TO BE DISLODGED. UPON DEVICE INTERROGATION, IT WAS SEEN THAT THE PATIENT RECEIVED AN ALERT FOR HIGH IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9000 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |