BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 3923137 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14470
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR THE A ROUTINE CLINIC VISIT. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP OPERATION. THE DEVICE EXHIBITED A SOFTWARE CODE ANOMALY AND COULD NOT BE TROUBLESHOOTED. A DEVICE REPLACEMENT WOULD BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400858 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR