FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR ICD, US
MDR report key: 4850694
·
Received June 17, 2015
Report
- Report Number
- 2938836-2015-26540
- Event Type
- Malfunction
- Date Received
- June 17, 2015
- Date of Event
- April 23, 2015
- Report Date
- April 23, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING AN ALERT THAT THE DEVICE WAS IN BACK-UP VVI MODE. A DEVICE DOWNLOAD WAS SUCCESSFULLY PERFORMED TO RESTORE THE DEVICE. PATIENT'S CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395084 | FORTIFY ASSURA DR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2357-40C | 4514538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |