BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2132010 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00224
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. THE MAIN PRINTED CIRCUIT BOARD OUT OF SPECIFICATION. BATTERY DRAWER FOUND BROKEN. BATTERY RELEASE AND LEAD FLEX COVER FOUND CONTAMINATED. RING FOUND BENT. RING COVER AND TWO SIDE BAIL COVERS FOUND BROKEN, AND THE UPPER AND LOWER CASES FOUND BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAD LOW ATRIAL OUTPUT. FOLLOW-UP INFORMATION RECEIVED DETERMINED THERE WAS NO PATIENT INVOLVEMENT. THE CONDITION WAS FOUND DURING A PREVENTATIVE MAINTENANCE CHECK. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other