FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D
MDR report key: 4092016
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-05099
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- March 15, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE DEVICE WENT INTO BACKUP VVI. THE PHYSICIAN DELIVERED EXTERNAL DEFIBRILLATION DURING DFT TESTING, CAUSING THE DEVICE TO EXPERIENCE A POWER ON RESET. THE DEVICE WAS RESTORED AND REMAINS IN THE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22831 | UNIFY QUADRA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL INC., CRMD | CD3249-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |