BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1072470 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00362
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    February 27, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY: (B) (4) BATTERY DEPLETION-NORMAL. (B) (4) IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO HIGH THRESHOLD THROUGH DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B) (4) ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED; (B) (4 )ELECTRICAL TESTS PERFORMED; (B) (4 )MECHANICAL TESTS PERFORMED. (B) (4) VISUAL EXAMINATION: (B) (4) BATTERY; (B) (4) END OF LIFE - EXPECTED. (B) (4) DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED; H(B) (4)HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO HIGH THRESHOLD THROUGH DEVICE. NO PATIENT COMPLICATIONS WERE 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 MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD