FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3101228
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02012
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 22, 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
- TN
- 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 PATIENT HAD UNSUCCESSFUL DFT TESTING AT IMPLANT. AN ATTEMPTED COURSE OF SOTALOL WAS TRIED, BUT IT DISCONTINUED DUE TO THE PATIENTS REACTION. THE DEVICE WILL BE ELECTIVELY EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204049 | 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 | 69 YR |