BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 1862997 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05360
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THAT THE CURRENT OUTPUT OF THE PATIENT'S DEVICE WAS 6V AND 1.5 MS. THE PATIENT HAD A HIGH RIGHT VENTRICULAR THRESHOLD. THE CAPTURE THRESHOLD WAS RISING AND THE CALLER LATER STATED THAT THERE WERE REPORTS FROM A CLINICIAN THAT LOSS OF CAPTURE HAD OCCURED POST SHOCK. IT WAS ALSO STATED THAT THE PATIENT'S ELECTROLYTES MAY HAVE AFFECTED THE SITUATION. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 6945 IMPLANTABLE TACHY LEAD