FDA Adverse Event
Injury
Summary report: N
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
MDR report key: 5947343
·
Received September 13, 2016
Report
- Report Number
- 2938836-2016-11350
- Event Type
- Injury
- Date Received
- September 13, 2016
- Date of Event
- August 8, 2016
- Report Date
- August 8, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED INTO THE EMERGENCY WITH MULTIPLE INAPPROPRIATE SHOCKS FOR AF WITH RVR. SOME EPISODES WERE FALLING INTO THE VF ZONE AND MANY P-WAVES WERE BLANKED BY R-WAVES. SINCE THE PATIENT STOPPED USING MEDICATION, RECOMMENDED PROGRAMMING CHANGES WERE NOT MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597331 | CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2257-40Q | 3858028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |