FDA Adverse Event
Malfunction
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 2902682
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00422
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- October 5, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 PATIENT WAS BROUGHT IN-CLINIC AFTER TRANSMITTING TO (B)(4). THE DEVICE WAS FOUND TO BE IN BACKUP AFTER DETECTING A POR. THE PATIENT REPORTED RECEIVING A MRI AROUND THE TIME OF THE BACKUP. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS OF PANCREATIC CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9570 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |