BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 2205860 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-05103
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    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
    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 (B)(4) COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) POWER ON RESET - POWER ON RESET PARAMETERS (B)(4) 1 - POR FOR WRITE TO LOCKED RAM, ADDR=11CA, DATA=EE, ON (B)(4)-2006 16:14:53.1 - PATIENT ALERT FOR POR ON (B)(4)-2006 15:14:53.

    Description of Event or Problem · 1

    POWER ON RESET PARAMETERS. IT WAS ALSO REPORTED THAT AN ELECTRICAL RESET WAS NOTED ON DEVICE INTERROGATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL; IT IS UNKNOWN IF THERE WAS ANY INTERVENTION. THE DEVICE 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 74 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD