BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 1875080 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05445
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    March 18, 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
    CA, 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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED POWER ON RESET - POWER ON RESET PARAMETERS. WRITE TO LOCKED RANDOM ACCESS MEMORY (RAM) POWER ON RESET (POR) RECORDED ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010. MULTIPLE PARITY ERRORS ARE RECORDED (B)(6). THIS IS COMMON FOR PATIENTS RECEIVING RADIATION TREATMENT. POR SEVERITY WAS LOW AND THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: CHANGE MADE TO DEVICE CONCLUSION. 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 RANDOM ACCESS MEMORY (RAM) POWER ON RESET (POR) RECORDED ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010. MULTIPLE PARITY ERRORS ARE RECORDED (23). THIS IS COMMON FOR PATIENTS RECEIVING RADIATION TREATMENT. POR SEVERITY WAS LOW AND THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED POWER ON RESET - POWER ON RESET PARAMETERS. WRITE TO LOCKED RANDOM ACCESS MEMORY (RAM) POWER ON RESET (POR) RECORDED ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010. MULTIPLE PARITY ERRORS ARE RECORDED (23). THIS IS COMMON FOR PATIENTS RECEIVING RADIATION TREATMENT. POR SEVERITY WAS LOW AND THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS UNDERGOING RADIATION THERAPY AND THE DEVICE COMPLETED SEVERAL POWER ON RESETS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE TACHY LEAD