BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 3923167 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14484
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400991 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention