BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2202920 · Received August 11, 2011

    Report

    Report Number
    2183613-2011-00365
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 5, 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
    PA, 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. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE INITIAL REPORT, THE MAIN PRINTED CIRCUIT (PC) BOARD WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN, THE RING COVER WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER WAS BROKEN AND THE BATTERY RELEASE WAS CONTAMINATED.

    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EPG (EXTERNAL PULSE GENERATOR) WAS POWERED ON, IT IMMEDIATELY TURNED BACK OFF. 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