BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ST, DF-4 CONNECTOR

    MDR report key: 4091762 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04970
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 3, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF NO RF TELEMETRY COULD NOT BE REPLICATED IN THE LABORATORY. THE DEVICE WAS TESTED AND BOTH THE RF AND INDUCTIVE TELEMETRY FUNCTIONS WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT, BEFORE REMOVAL FROM STERILE PACKAGING, THE DEVICE COULD ESTABLISH AN RF CONNECTION. INDUCTIVE TELEMETRY WAS NORMAL. THE DEVICE WAS NOT IMPLANTED AND A REPLACEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33755 FORTIFY ST, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2241-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1