BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRELUDE DR

    MDR report key: 2791078 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03315
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH HAS BEEN IMPLANTED GREATER THAN 5 YEARS, WAS PACING ASYNCHRONOUSLY AFTER DEFIBRILLATION. THE DEVICE WAS PROGRAMMED TO AAI MODE TO PROVIDE THERAPY. THE DEVICE HAS SINCE BEEN EXPLANTED AND REPLACED DUE TO UPGRADE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRELUDE DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC, INC. 1226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention