BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2132064 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00257
    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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FOUND THAT THE LCD DISPLAY WAS OUT OF SPECIFICATION. IT WAS NOTED THAT THE UPPER CASE, LOWER CASE, TWO SIDE BAIL COVERS, RING COVER AND BATTERY DRAWER WERE BROKEN. THE HEART BLOCK AND LEAD FLEX COVER WERE FOUND CONTAMINATED. TWO SIDE BAILS AND THE RING WERE BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOWER DISPLAY WAS MISSING SEGMENTS. THE DEVICE WAS RETURNED, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT WAS REPORTED WITH THIS EVENT.

    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