FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3210542
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03442
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 5, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 FOR ROUTINE FOLLOW UP, INAPPROPRIATE MODE SWITCHING DUE TO FARFIELD OVERSENSING AND RISING CAPTURE THESHOLD WERE OBSERVED. THE DEVICE WAS REPROGRAMMED. THE LEAD WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310203 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |