BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX SR

    MDR report key: 750617 · Received August 9, 2006

    Report

    Report Number
    2124215-2006-15168
    Event Type
    Malfunction
    Date Received
    August 9, 2006
    Date of Event
    May 3, 2006
    Report Date
    May 3, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    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 THIS PACEMAKER WAS REPORTED TO BE PACING AT A RATE OF 130 BEATS PER MINUTE, WITH THE PATIENT HOSPITALIZED AND AT REST. THE PROGRAMMED SETTINGS ARE: MAX SENSOR RATE (MSR)=185; LOWER RATE LIMIT(LRL)=60. THIS DEVICE IS INCLUDED IN THE HERMETIC SEAL ADVISORY. THERE WAS NO CHANGE IN THE PACING RATE WHEN THE MINUTE VENTILATION WAS TURNED OFF, WHEN THE ACCELEROMETER WAS TURNED OFF THE RATE WENT TO THE LRL OF 60. THE NEXT DAY IT WAS REPORTED THE DEVICE AGAIN EXHIBITED THIS BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX SR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS, INC 1171 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other