FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR ICD, US
MDR report key: 4821653
·
Received June 5, 2015
Report
- Report Number
- 2938836-2015-26479
- Event Type
- Malfunction
- Date Received
- June 5, 2015
- Date of Event
- April 3, 2015
- Report Date
- April 3, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEPENDENT PATIENT PRESENTED WITH SEVERAL NON-SUSTAINED NOISE EPISODES DUE TO MYOPOTENTIAL OVERSENSING. PROGRAMMING CHANGE WAS MADE. THE PATIENT WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364101 | FORTIFY ASSURA DR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2357-40C | 4477874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |