BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2293224 · Received October 13, 2011

    Report

    Report Number
    6000144-2011-06169
    Event Type
    Injury
    Date Received
    October 13, 2011
    Date of Event
    August 8, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 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. 2 - PORS FOR WRITE TO LOCKED RAM, ON (B)(4) 2011 09:43:24, ADDR=101E, DATA=01, AND (B)(4) 2011 09:41:08, ADDR=0C2D, DATA=5D. 1 - PATIENT ALERT FOR POR ON (B)(4) 2011 08:41:08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE RECEIVED A POWER ON RESET. THE PATIENT IS UNDERGOING RADIATION TREATMENT ON THE SAME SIDE AS THE DEVICE IS IMPLANTED. THE DEVICE WAS REPROGRAMMED TO THE PROPER SETTINGS AND REMAINS 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4) IMPLANTABLE TACHY LEAD