BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1863358 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00810
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    May 27, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS RETURNING FROM THE OR (OPERATING ROOM) AFTER HAVING S/P CABG (STATUS POST CORONARY ARTERY BYPASS GRAFT) X 2, WITH EPICARDIAL WIRES CONNECTED TO THE EPG (EXTERNAL PULSE GENERATOR). UPON ARRIVAL, IT WAS NOTICED THAT THE DEVICE WAS NOT WORKING AND HAD AN ERROR READING ON IT. ANOTHER DEVICE WAS USED. THE DEVICE WAS SENT TO THE BIOMED, BUT THE BIOMED COULD NOT FIND ANYTHING WRONG WITH IT. THE STAFF SAID THE ERROR OCCURRED WHEN THE DEVICE WAS POWERED ON, SO ANOTHER DEVICE WAS USED. 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, INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention