FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 4240752
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17730
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 8, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED INTO CLINIC FOR FOLLOW UP, THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. THE DEVICE CODE DOWNLOAD WAS PERFORMED SUCCESSFULLY AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723696 | UNIFY ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3257-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |