BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 2811591 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06088
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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. PERFORMANCE DATA FOR FILE (B)(6) SHOWS LAST BATTERY VOLTAGE = "V" IS MISSING DATA ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO BATTERY VOLTAGE MEASUREMENT WAS PROVIDED FOLLOWING THE MOST RECENT REMOTE MONITORING TRANSMISSION. THE CUSTOMER WAS ASSISTED AND PROVIDED WITH THE MOST RECENT MEASUREMENT FROM EXISTING DATA. 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 II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other 6949 IMPLANTABLE TACHY LEAD