FDA Adverse Event
Injury
Summary report: N
FORTIFY DR
MDR report key: 3090121
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01184
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- June 29, 2012
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED EXTENDED CHARGE TIME WAS DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXTENDED CHARGE TIME DUE TO LOW BATTERY VOLTAGE WAS OBSERVED. MULTIPLE SHOCKS HAD BEEN DELIVERED AND SEVERAL SHOCKS WERE ABORTED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191173 | FORTIFY DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2233-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |