FDA Adverse Event
Injury
Summary report: N
FORTIFY VR, DF-4 CONNECTOR
MDR report key: 3890216
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04463
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- October 13, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN EPISODE OF INAPPROPRIATE ATP THERAPY WAS OBSERVED. IT WAS RESOLVED BY ADJUST SVT DETECT CRITERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34493 | FORTIFY VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS | LWS | ST. JUDE MEDICAL INC., CRMD | CD1231-40Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention |