FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220041
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04597
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 2, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT WAS FAR FIELD P-WAVE OVERSENSING AND POSSIBLY OVERSENSING MYOPOTENTIALS ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY. THE OVERSENSING WAS NOTED ON A STORED NON SUSTAINED LEAD NOISE EGM. REPROGRAMMING OF THE DEVICE WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321289 | UNIFY ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3261-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |