BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY XL DR

    MDR report key: 3923150 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14479
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PULSE GENERATOR HAD INCORRECT IDENTIFICATION INFORMATION STORED. PAST RECORDS WERE UNAVAILABLE. THE CAUSE WAS UNKNOWN BUT THE CORRECT VALUES WERE PROGRAMMED INTO THE DEVICE. THE PATIENT WOULD BE MONITORED WITH ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401490 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5376 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR