BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131700 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00320
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 CUSTOMER COMMENT. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, ONE CONTROL KNOB WAS BROKEN, THE RING COVER WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE OUT OF SPECIFICATION, THE RING WAS BENT, ONE SIDE BAIL WAS MISSING AND THE ENCODER FLEX AND BATTERY FLEX WERE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SELF-TEST ERROR OCCURRED. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    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