BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1861778 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01873
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 3, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION AND COULDN'T BE INTERROGATED. A PREVIOUS INTERROGATION ON (B)(6) 2010, SHOWED TWO YEARS REMAINING LONGEVITY. IT WAS ALSO NOTED THAT THE PATIENT'S HEART RATE DROPPED TO 46. THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE 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 72 YR Required Intervention