FDA Adverse Event
Malfunction
Summary report: N
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
MDR report key: 4863832
·
Received June 23, 2015
Report
- Report Number
- 2938836-2015-26933
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Date of Event
- April 22, 2015
- Report Date
- April 22, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. MYOPOTENTIALS WERE ABLE TO BE RECREATED IN CLINIC VIA DEEP BREATHING. PROGRAMMING CHANGES WERE RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406993 | CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2257-40Q | 3999438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |