BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 2983736 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01601
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 18, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING THE PULSE GENERATOR INTERROGATION INTERMITTENT VENTRICULAR CAPTURE WAS NOTED. THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE DEVICE REVERTED TO BACKUP VVI MODE AND WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87866 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention