FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR, DF-4 CONNECTOR
MDR report key: 3901000
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12599
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS SUSPECTED TO BE DEFECTIVE AND BROKEN AND CAUSED FIVE HEART ATTACKS TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380002 | FORTIFY DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |