BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1991851 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00956
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 DURING THE DEVICE IMPLANT, AN ATRIAL-VENTRICULAR NODE ABLATION PROCEDURE WAS PERFORMED, AND A WARNING WAS RECEIVED DUE TO DEVICE LOW BATTERY VOLTAGE. IN ADDITION, IT WAS REPORTED THAT THERE WAS A DEVICE RESET. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR403 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R