BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 1863213 · Received October 9, 2010

    Report

    Report Number
    6000094-2010-01929
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 22, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS PACING RATE WAS LOWER THAN PROGRAMMED. THE PATIENT IS UNDERGOING DIALYSIS. DEVICE TESTING ON DAY OF DIALYSIS SHOWED NORMAL LEAD IMPENDANCE, ATRIAL FIBRILLATION, BUT GOOD THRESHOLDS, ALSO A BRIEF RUN OF VENTRICULAR FIBRILLATION AFTER LOSS OF CAPTURE. THE DEVICE IS STILL 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 S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R 6947 IMPLANTABLE TACHY LEAD