BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1072708 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00305
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 16, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: VISUAL ANALYSIS UPON RECEIPT REVEALED THAT THE CONNECTOR BLOCK WAS DETACHED. THE CAUSE OF THE NO ATRIAL OUTPUT WHILE IMPLANTED WAS A FRACTURED ATRIAL FEEDTHROUGH WIRE CAUSED BY THE CONNECTOR BLOCK BECOMING DETACHED. THE EXACT CAUSE OF WHY THE CONNECTOR SEPARATED IS UNKNOWN. IT WAS REPORTED THE DEVICE HEADER BLOCK WAS FOUND COMPLETELY SEPARATED FROM THE PULSE GENERATOR AT EXPLANT. AS A RESULT, THE DEVICE WAS EXHIBITING UNDEFINED IMPEDANCES, NO CAPTURE AND NO PACING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ELECTRICAL TESTS PERFORMED ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION, COMPONENT/SUBASSEMBLY FAILURE DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT CAPTURE, FAILURE TO IMPEDANCE, HIGH PACE, FAILURE TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HEADER BLOCK WAS FOUND COMPLETELY SEPARATED FROM THE PULSE GENERATOR AT EXPLANT. AS A RESULT, THE DEVICE WAS EXHIBITING UNDEFINED IMPEDANCES, NO CAPTURE AND NO PACING. THE DEVICE WAS REPLACED. 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 S.A. KDR706 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R