FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D QUAD RF HV
MDR report key: 6178967
·
Received December 15, 2016
Report
- Report Number
- 2938836-2016-18123
- Event Type
- Malfunction
- Date Received
- December 15, 2016
- Date of Event
- November 22, 2016
- Report Date
- November 22, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NIK
- PMA / PMN Number
- P970013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW-UP WITH DEVICE IN BACKUP VVI RESET MODE. FIRMWARE DOWNLOAD WAS PERFORMED AND SUCCESSFULLY RESTORED THE DEVICE. THE PARAMETERS WERE REPROGRAMMED AND THE PATIENT WILL BE FOLLOWED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830551 | QUADRA ASSURA CRT-D QUAD RF HV | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD3365-40C | 4488546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |