FDA Adverse Event
Injury
Summary report: N
FORTIFY VR
MDR report key: 3920908
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13328
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- March 3, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE ATP AND HV THERAPIES DUE TO SINUS TACHYCARDIA. THE PATIENT WAS DOING WELL AT THE NEXT FOLLOW-UP. THE DEVICE WAS LATER EXPLANTED AND REPLACED FOR UPGRADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398300 | FORTIFY VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1231-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |