BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 1955298 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00478
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    December 7, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS FOUND TO BE IN BACKUP VVI RESET MODE. ANALYSIS OF THE DEVICE IMAGE INDICATES THAT THE RESET OCCURRED AFTER THE PATIENT EXPIRED. THERE IS NO INDICATION OF INAPPROPRIATE DEVICE BEHAVIOR DURING THE IMPLANT PERIOD. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL TEST SYSTEM; ALL DEVICE FUNCTIONS WERE NORMAL.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPIRED, CAUSE UNKNOWN. THE PHYSICIAN SUSPECTS THAT THE DEVICE WAS NOT FUNCTIONING NORMALLY AND WAS NOT DELIVERING ELECTRONIC IMPULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 7120Q/58, (B)(4), 1888T/52, (B)(4)