FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA ICD
MDR report key: 6028334
·
Received October 13, 2016
Report
- Report Number
- 2938836-2016-11465
- Event Type
- Malfunction
- Date Received
- October 13, 2016
- Date of Event
- August 3, 2016
- Report Date
- August 3, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. THE BACKUP WAS SUSPECTED TO BE RELATED TO TELEMETRY ISSUES BETWEEN THE TRANSMITTER AND THE PM. A SOFTWARE DOWNLOAD WAS PERFORMED AND THE DEVICE WAS RESTORED SUCCESSFULLY. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677858 | UNIFY ASSURA ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD3361-40Q | 4355222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |