BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 3781744 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09885
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY WHEN THE ATP THERAPY ACCELERATED THE RHYTHM TO THE VF ZONE. THE DEVICE WAS REPROGRAMMED AND THE PATIENT HAD A SUCCESSFUL VT ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260109 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention