FDA Adverse Event
Injury
Summary report: N
UNIFY ASSURA DR CRT-D
MDR report key: 4130787
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16108
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- August 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 ONE DAY POST IMPLANT OF THE DEVICE THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH ALERTS FOR NON-SUSTAINED RV OVERSENSING. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. THE POCKET WAS RE-OPENED AND ALL LEAD CONNECTIONS WERE NORMAL. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607397 | UNIFY ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3357-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |