FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220355
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04590
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 17, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- 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 WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC FOR A ROUTINE FOLLOW-UP, A HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE ALERT WAS NOTED. THE DEVICE SHOWED NO MEASUREMENTS FOR RV TO SVC AND SVC TO CAN. IT WAS NOTED THAT THE LEAD DID NOT HAVE AN SVC COIL. THE DEVICE WILL BE REPROGRAMMED. THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319794 | UNIFY ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |