BEUDAMED
    FDA Adverse Event Summary report: N

    ASKU

    MDR report key: 1873126 · Received October 18, 2010

    Report

    Report Number
    2183613-2009-00015
    Date Received
    October 18, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER UP CORRECTLY, WHICH DIFFERS FROM THE REPORTED EVENT, AND THE MAIN PC (PRINTED CIRCUIT) BOARD WAS FOUND TO BE OUT OF SPECIFICATION. SUBSEQUENT EVALUATION OF THE MAIN PC BOARD COULD NOT REPRODUCE THE REPORTED BEHAVIOR. BOTH SIDE BAIL COVERS AND THE TOP RING COVER WERE FOUND TO BE BROKEN.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4)ANALYSIS FOUND THE DEVICE WOULD NOT POWER UP. THE CAUSE WAS THE MAIN PCB (PRINTED CIRCUIT BOARD). BOTH SIDE BAIL COVERS AND THE TOP RING COVER WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE POWERED OFF ON ITS OWN. A MEDWATCH 3500A WAS SUBSEQUENTLY RECEIVED REPORTING THE PATIENT WAS BEING PACED FOR COMPLETE HEART BLOCK. THE PACER "FAILED (STOPPED)." THE PATIENT WAS ASYSTOLE WITHOUT THE DEVICE. THE BATTERIES WERE CHANGED, AND THE DEVICE SWITCHED OUT. THERE WAS REPORTED TO BE NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU ASKU DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention