BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1924488 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02263
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 18, 2003
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, THE PHYSICIAN GOT A MESSAGE INDICATING THE DEVICE HAD EXPERIENCED AN ELECTRICAL RESET WHICH OCCURRED BEFORE THE IMPLANT DATE. THE MESSAGE WAS CLEARED, AND 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 S.A. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention