BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 1988914 · Received February 14, 2011

    Report

    Report Number
    6000144-2011-00483
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    November 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET - POWER ON RESET PARAMETERS 1 - POR FOR WRITE TO LOCKED RAM, ADDRESS=1191, DATA=01 ON (B)(4)-2010 12:30:47. 1 - PATIENT ALERT FOR POR ON (B)(4)-2010 12:30:47.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON REST. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other 5072 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD