FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ST DR
MDR report key: 4133716
·
Received October 1, 2014
Report
- Report Number
- 2938836-2014-16299
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- August 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR FOLLOW UP WITH THE DEVICE IN BACK-UP VVI. A SUCCESSFUL DOWNLOAD WAS PERFORMED AND THE DEVICE WAS RESTORED. AN EXTENDED CHARGE TIME WAS ALSO NOTED. REVIEW OF THE DEVICE IMAGE REVEALED THE DEVICE DELIVERED A LARGE AMOUNT OF SHOCKS AND THE BACK-UP VVI WAS DUE TO EXCESSIVE CHARGING. DUE TO THE PATIENTS POOR CLINICAL CONDITION, THE PHYSICIAN ELECTED NOT TO REPLACE THE DEVICE. THE PATIENT CONDITION WAS OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611080 | FORTIFY ST DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |