BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2132067 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00259
    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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE HEART LEAD FLEX FOUND OUT OF SPECIFICATION. THE BATTERY RELEASE FOUND CONTAMINATED, UPPER AND LOWER CASES BROKEN, RING COVER CONTAMINATED AND TWO SIDE BAIL COVERS BROKEN, RING BENT AND ONE SIDE BAIL MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT FAILED A CURRENT DRAIN LOAD TEST. IT WAS ALSO REPORTED THERE WAS NO MEASUREABLE OUTPUT ON BOTH ATRIAL AND VENTRICULAR CHANNELS. THERE WAS NO PATIENT INVOLVEMENT. THE CONDITION WAS FOUND DURING PREVENTATIVE MAINTENANCE. THE EXTERNAL PULSE GENERATOR 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