BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SERIES 200 PULSE GENERATOR

    MDR report key: 116711 · Received August 19, 1997

    Report

    Report Number
    2522457-1997-00012
    Event Type
    Injury
    Date Received
    August 19, 1997
    Date of Event
    July 18, 1997
    Report Date
    July 22, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 12/11/96, A 84 YR OLD MALE PT UNDERWENT A PACEMAKER IMPLANT WITH ANOTHER MFR'S LEAD. ON 7/18/97, IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE POCKET SITE. ON 7/18/97, THE PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND CAPPED OFF THE LEAD. A NEW PACEMAKER FROM THE CO WAS IMPLANT WITH ANOTHER MFR'S LEAD. COMPLICATION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SERIES 200 PULSE GENERATOR Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC 231 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization