BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1992191 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00053
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REPORTED SHUTTING DOWN AFTER EMERGENCY MODE. ANALYSIS CONFIRMED THE REPORTED BROKEN LCD LENS. LOWER CASE AND TWO SIDE BAIL COVERS ARE BROKEN. BATTERY CONTACTS ARE COMPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT WAS CONNECTED TO A PATIENT WHEN IT WENT INTO EMERGENCY PACING AND THEN SHUT OFF. THE UNIT WAS SWITCHED TO A DIFFERENT ONE, AND THE SITUATION WAS RESOLVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. A CRACK IN THE LCD PLASTIC WAS ALSO NOTED.

    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 Required Intervention