BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SAVVI SERIES 300 PULSE GENERATOR

    MDR report key: 106391 · Received July 16, 1997

    Report

    Report Number
    2522457-1997-00008
    Event Type
    Injury
    Date Received
    July 16, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 17, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3/8/91, A 70 YEAR OLD MALE PT WAS IMPLANTED WITH A SINGLE-LEAD ATRIAL SYNCHRONOUS VENTRICULAR PACEMAKER SYSTEM. ON 9/19/06, THE PT PRESENTED FOR A PACEMAKER REPLACEMENT DUE TO NORMAL BATTERY DEPLETION. A NEW PACEMAKER WAS IMPLANTED WITH THE EXISTING LEAD. ON 6/16/97, THE MFR RECEIVED A REPORT THAT THE ABOVE REFERENCED PT HAD PRESENTED WITH LOSS OF VENTRICULAR PACING DUE TO A LEAD FRACTURE. ON 6/11/97, THE PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND CAPPED OFF THE EXISTING LEAD. A NEW PACEMAKER AND LEAD WERE IMPLANTED AND THE COMPLICATION WAS RESOLVED. THE EXPLANTED PACEMAKER AND LEAD WAS NOT RETURNED TO THE MFR FOR AN EVALUATION THEREFORE, NO FUNCTIONAL ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SAVVI SERIES 300 PULSE GENERATOR Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC 325 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization