BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131573 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00299
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT REGARDING THE UPPER AND LOWER CASES BEING BROKEN. IT WAS ALSO NOTED THAT THE THREE CONTROL KNOBS, HEART WIRE BLOCK, RING COVER, THREE KNOB SPRINGS, AND HEART WIRE CONTACTS WERE CONTAMINATED. IT WAS ALSO NOTED THAT TWO SIDE BAIL COVERS WERE BROKEN, THE RING WAS BENT AND TWO SIDE BAILS WERE MISSING. ALSO, THE INTERCONNECT FLEX WAS OUT OF SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS BROKEN AND THE CONNECTOR WAS DAMAGED. THE DEVICE WAS RETURNED FOR SERVICE. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other