BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1854894 · Received October 5, 2010

    Report

    Report Number
    2182208-2010-00661
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 A QUESTION WAS RECEIVED ASKING IF, AS A DEVICE APPROACHES ELECTIVE REPLACEMENT INDICATOR (ERI), THERE IS AN INCREASED CHANCE OF EVOKED RESPONSE UNDERSENSING LEADING TO CAPTURE MANAGEMENT PROGRAMMING CHANGES WHICH COULD ACCELERATE ERI TO HAPPEN SOONER THAN EXPECTED. THE STATUS OF THE DEVICE IS UNKNOWN. 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 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other