FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3220331
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04392
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 16, 2013
- 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
- AL
- 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 AN ASYMPTOMATIC, PACER DEPENDENT PATIENT PRESENTED TO THE CLINIC FOR ROUTINE FOLLOW-UP. UPON REVIEW OF THE NON-SUSTAINED VF AND NOISE REVERSION EPISODES, INAPPROPRIATE BINNING OF FIB AND BRIEF INHIBITION OF PACING WAS NOTED. NOISE WAS REPRODUCIBLE WITH ISOMETRIC TESTING AND POCKET MANIPULATION. THE LEAD IS SCHEDULED FOR REPLACEMENT. THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319727 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |