BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO SERIES 200

    MDR report key: 37441 · Received September 5, 1996

    Report

    Report Number
    2522457-1996-00001
    Event Type
    Injury
    Date Received
    September 5, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 30, 1996
    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 10/12/94, THE PT WAS IMPLANTED WITH A SINGLE-CHAMBER VENTRICULAR PACEMAKER AND ANOTHER MFR'S LEAD. PT PRESENTED WITH LOSS OF VENTRICULAR PACING. BOTH THE PACEMAKER AND THE OTHER MFR'S LEAD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO SERIES 200 Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC. 232 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization