BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 1992502 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-01008
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO THE EMERGENCY ROOM THE DAY AFTER SURGERY DUE TO THE DEVICE ALARM SOUNDING TWICE. IT WAS DISCOVERED THE DEVICE WAS LOOKING FOR A WIRE THAT WAS NO LONGER NEEDED, WHICH TRIGGERED THE ALARM. IT WAS ALSO NOTED THREE OF THE THERAPIES FOR THE DEFIBRILLATION COMPONENT OF THE DEVICE WERE NOT TURNED ON. THE PATIENT WAS VERY UPSET AND EXPRESSED DISSATISFACTION WITH THE PROGRAMMING OF THE DEVICE ON THE DAY OF SURGERY. THE DEVICE REMAINS IN USE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR