BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1992188 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00051
    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
    AK, 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 EVENT. ELECTRICAL TESTING SHOWED NO ANOMALIES. THE BATTERY DRAWER AND SIDE BAIL COVERS WERE ALSO OBSERVED TO BE BROKEN. THE VISUAL ANOMALIES NOTED WOULD NOT HAVE CAUSED THE REPORTED BEHAVIOR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOSPITAL STAFF THAT THE EPG (EXTERNAL PULSE GENERATOR) TURNED ITSELF OFF WHILE CONNECTED TO A PATIENT. THEY THEN REPLACED THE BATTERY, BUT AGAIN THE DEVICE TURNED ITSELF OFF, SO THEY REPLACED THE DEVICE. THERE WAS NO PATIENT INJURY 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 Required Intervention