FDA Adverse Event
Malfunction
Summary report: N
FORTIFY VR, U1.6 SJ4 US
MDR report key: 6032715
·
Received October 16, 2016
Report
- Report Number
- 2938836-2016-12835
- Event Type
- Malfunction
- Date Received
- October 16, 2016
- Date of Event
- September 2, 2016
- Report Date
- September 2, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT WAS PRESENTED TO THE HOSPICE CENTER TO DISABLE TACHYCARDIA THERAPY FOR END OF LIFE CARE. PATIENT'S WIFE SUSPECTED THAT THE PATIENT RECEIVED SEVERAL SHOCKS. DEVICE COULD NOT BE INTERROGATED DUE TO DEVICE BEING RESET HENCE PATIENT'S THERAPY DETAILS WERE UNAVAILABLE. A DEVICE IMAGE WAS NOT ABLE TO BE DOWNLOADED FROM THE DEVICE. NO ACTION WAS TAKEN. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683877 | FORTIFY VR, U1.6 SJ4 US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD1231-40Q | 3421596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |