FDA Adverse Event
Death
Summary report: N
FORTIFY ST DR, DF4 CONNECTOR
MDR report key: 3090131
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01189
- Event Type
- Death
- Date Received
- May 2, 2013
- Date of Event
- March 6, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT EXPIRED, THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SOFTWARE UPGRADE, HV THERAPY WAS DELIVERED. A MAGNET WAS PLACED ON THE ICD HOWEVER, ANOTHER HV THERAPY WAS DELIVERED. IT WAS NOTED THAT THE DEVICE WAS IN BACKUP VVI MODE. THE PATIENT WAS SEDATED AND THERAPY WAS DISABLED. SOFTWARE UPGRADE WAS PERFORMED SUCCESSFULLY AT SUBSEQUENT FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192320 | FORTIFY ST DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death| R |