FDA Adverse Event
Injury
Summary report: N
FORTIFY DR, DF-4 CONNECTOR
MDR report key: 3880119
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-02247
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- November 29, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 THE PATIENT RECEIVED INAPPROPRIATE ATP AND SHOCK THERAPY. TECH SERVICE RECOMMENDED DISABLING THE ATRIOVENTRICULAR INTERVAL DELTA AND INCREASING THE VENTRICULAR FIBRILLATION ZONE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24300 | FORTIFY DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS | LWS | ST. JUDE MEDICAL INC., CRMD | CD2231-40Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |