BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL DR, 36J

    MDR report key: 6907004 · Received October 2, 2017

    Report

    Report Number
    2938836-2017-32380
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    August 30, 2017
    Report Date
    October 2, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. ADDITIONALLY, AFTER A SOFTWARE UPGRADE AN ERROR MESSAGE WAS DISPLAYED INDICATING AN FSM STATE ACTION ERROR. THE DEVICE WAS RESTORED TO NORMAL FUNCTION. THE PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687598 CURRENT ACCEL DR, 36J IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2215-36 3095372

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR