FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA DR CRT-D
MDR report key: 4173893
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16693
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
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 THE EMERGENCY ROOM AFTER PATIENT NOTIFIER WAS DELIVERED FOR BVVI. DEVICE DOWNLOAD WAS DONE AND WAS SUCCESSFUL TO RETURN THE DEVICE TO NORMAL OPERATION. PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655222 | UNIFY ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3357-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |