BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1992199 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00059
    Event Type
    Malfunction
    Date Received
    February 15, 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
    OR, 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. UPPER AND LOWER CASES ARE BROKEN. RING COVER AND TWO SIDE BAIL COVERS ARE BROKEN. LEAD FLEX COVER AND BATTERY DRAWER ARE BROKEN. TWO SIDE BAILS ARE BENT. ENCODER FLEX IS OUT OF SPECIFICATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ABOUT TEN MINUTES OF OPERATION, THE UNIT LOCKS UP. THE ONLY RESPONSIVE KEY IS "EMERGENCY." INFORMATION WAS SUBSEQUENTLY RECEIVED REPORTING THERE WAS NO PATIENT INVOLVEMENT. THE CONDITION WAS FOUND DURING PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ABOUT TEN MINUTES OF OPERATION, THE UNIT LOCKS UP. THE ONLY RESPONSIVE KEY IS "EMERGENCY." NO PATIENT 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. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other