FDA Adverse Event
Injury
Summary report: N
FORTIFY ST VR, DF-4 CONNECTOR
MDR report key: 3080218
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00999
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- February 25, 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
THE REPORTED FIELD EVENT OF BACKUP DFO RESET AND INAPPROPRIATE SHOCKS WERE CONFIRMED. THE CAUSE OF THE RESET TO BACKUP DFO MODE WAS NOT DETERMINED. THE CAUSE OF THE INAPPROPRIATE THERAPY WAS DETERMINED TO BE OVERSENSING WHILE THE DEVICE WAS IN BACKUP DFO MODE. THE CAUSE OF THE OVERSENSNG IN BACKUP DFO MODE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING SEVERAL SHOCKS. THE DEVICE COULD NOT BE INTERROGATED AND WAS FOUND IN BACK VVI MODE. REVIEW OF THE DEVICE IMAGE SHOWED NO STORED EPISODES. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182796 | FORTIFY ST VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |