BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SERIES 500 PULSE GENERATOR

    MDR report key: 89930 · Received May 6, 1997

    Report

    Report Number
    2522457-1997-00006
    Event Type
    Injury
    Date Received
    May 6, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 7, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/13/96 AN 80-YEAR-OLD FEMALE PT WAS IMPLANTED WITH A DUAL-CHAMBER PACEMAKER AND TWO EXISTING LEADS FROM ANOTHER MFR. THE INDICATION FOR PACING WAS SICK SINUS SYNDROME. 0N 04/07/97, THE MFR RECEIVED A REPORT THAT THE ABOVE REFERENCED PT DEVELOPED EXCESSIVE POCKET STIMULATION 4.5 MONTHS POST-IMPLANT. ON 04/02/97, THE PHYSICIAN ELECTED TO EXPLANT THE PULSE GENERATOR AND REPLACE IT WITH A BIPOLAR PACEMAKER FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SERIES 500 PULSE GENERATOR Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC 533 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization