FDA Adverse Event
Malfunction
Summary report: N
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
MDR report key: 6097738
·
Received November 11, 2016
Report
- Report Number
- 2938836-2016-14108
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 11, 2016
- Report Date
- October 11, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR NORMAL DEVICE CHECK, INAPPROPRIATE AUTO MODE SWITCHING DUE TO CROSS-TALK WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE. PATIENTS CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748706 | CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2257-40Q | 3708969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |