BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY ADX DR

    MDR report key: 3920455 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14062
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 23, 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
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED DIAGNOSTICS ANOMALY. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396454 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1