BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 2130690 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03371
    Event Type
    Malfunction
    Date Received
    June 16, 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
    ID, 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. THE DATA SHOWED A POWER ON RESET (POR) PARAMETERS FOR WRITE TO LOCKED RAM ON (B)(6) 2011 19:10:11. PATIENT ALERT TRIGGERED FOR POR ON (B)(6) 2011 18:10:11.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE DEVICE HAS BEEN ALARMING FOR ABOUT A MONTH" AND THAT THERE WAS A POWER ON RESET OF THE DEVICE. 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 63 YR Other (B)(4) IMPLANTABLE TACHY LEAD