FDA Adverse Event
Injury
Summary report: N
FORTIFY VR
MDR report key: 3101119
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01907
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 27, 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 EXTENDED CHARGE TIME WAS CONFIRMED. THE CAUSE WAS DUE TO DAMAGE TO THE HIGH VOLTAGE CAPACITORS. WHEN THE HIGH VOLTAGE CAPACITORS WERE REPLACED, DEVICE FUNCTIONALITY WAS TESTED AND THE CHARGE TIMES WERE NORMAL.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING NORMAL FOLLOW UP, AN ALERT FOR CHARGE TIME LIMIT BEING REACHED WAS OBSERVED. EXTENDED CHARGE TIME WAS NOTED. DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203417 | FORTIFY VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1233-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |