BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 4160802 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01889
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY FOR WHAT APPEARS TO BE SUPRAVENTRICULAR TACHYCARDIA. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26642 FORTIFY DR, DF-4 CONNECTOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR