FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 2487104
·
Received March 10, 2012
Report
- Report Number
- 2017865-2012-02209
- Event Type
- Malfunction
- Date Received
- March 10, 2012
- Date of Event
- January 7, 2012
- 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 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 THE PATIENT PRESENTED IN THE ER AFTER RECEIVING INAPPROPRIATE THERAPY. THE DEVICE WAS FOUND IN BACKUP VVI MODE. OVERSENSING ON THE LEAD WAS OBSERVED VIA REVIEW OF EGMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |