BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSAR MAX II

    MDR report key: 674353 · Received February 9, 2006

    Report

    Report Number
    2124215-2006-11968
    Event Type
    Injury
    Date Received
    February 9, 2006
    Date of Event
    October 26, 2005
    Report Date
    October 26, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WENT TO THE ER WITH DIZZINESS DUE TO LOW BLOOD PRESSURE. WHILE IN THE ER, THE DEVICE HAD TWO EPISODES OF PACING BELOW THE PROGRAMMED LOWER RATE LIMIT (LRL). THE LRL IS SET TO 70 AND THESE BEAT ARE BELOW 60. TECHNICAL SERVICES STATES THERE MAY BE OVERSENSING. THE CALLER CHECKED THE DEVICE AND DID NOT FIND ANY OVERSENSING PROBLEMS. THE DEVICE CHECKED OUT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1280 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention