BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 400 DR

    MDR report key: 1854762 · Received October 5, 2010

    Report

    Report Number
    2647346-2010-00547
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS A POWER ON RESET (POR) AT THE SAME TIME AS A CT SCAN. THE DEVICE 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. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 5034 IMPLANTABLE PACING LEAD| 5534 IMPLANTABLE PACING LEAD