BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 SR

    MDR report key: 2368281 · Received December 12, 2011

    Report

    Report Number
    6000094-2011-02358
    Event Type
    Injury
    Date Received
    December 12, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVALUATION SUMMARY: (B)(4): UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A REGULAR FOLLOW-UP, LOW IMPEDANCE AND INCREASED THRESHOLD WERE FOUND. THE DEVICE WAS REPROGRAMMED TO OVO GIVEN THE PATIENT'S NON-DEPENDENCY. THE DEVICE WAS LATER EXPLANTED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). AT THAT TIME, THE LEAD MEASUREMENTS WERE NORMAL. 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 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KSR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R