BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 1861663 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04763
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 24, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED POWER ON RESET - (B)(4).

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED POWER ON RESET - POWER ON RESET PARAMETERS. WRITE TO LOCKED RAM POR RESIGTERED ON (B)(6) 2010 WITH ECC-LIA CONFLICT AT ADDRESS 69 CA. ADDITIONAL PARITY ERRORS ARE OBSERVED ON (B)(6) 2010. PATIENT ALERT LIST CONFIRMS "DEVICE CIRUIT ERROR" ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET DUE TO A MEMORY ERROR. 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 II DR ASKU LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD