BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2791324 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05342
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 24, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. POWER ON RESET (POR) PARAMETERS WERE NOTED WITH ONE POR FOR WRITE TO LOCKED RAM, ADDR EQUAL TO 154A, DATA EQUAL TO 2F ON (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR POR ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ELECTRICAL RESET WAS INDICATED ON A REMOTE TRANSMISSION. THE PATIENT WAS SEEN IN THE CLINIC, THE RESET WAS CLEARED, AND 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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD