BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131629 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00302
    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
    FL, 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 COULD NOT CONFIRM THE REPORTED EVENT. BATTERY DRAWER FOUND BROKEN. UPPER CASE, LOWER CASE, AND TWO SIDE BAIL COVERS FOUND BROKEN. BATTERY RELEASE, HEART BLOCK, AND LEAD FLEX COVER CONTAMINATED. RING FOUND BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME PARAMETERS ON THE EXTERNAL PULSE GENERATOR WERE UNABLE TO BE ADJUSTED AND THAT THE SETTINGS WERE ERRATIC. IT WAS FURTHER REPORTED THAT THE SELECTOR SWITCH (NEXT TO SELECT AND MENU) WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

    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