BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO II SAVVI SERIES 300 PULSE GENERATOR

    MDR report key: 51945 · Received November 20, 1996

    Report

    Report Number
    2522457-1996-00004
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    October 31, 1996
    Report Date
    October 31, 1996
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/31/96, THE MFR WAS NOTIFIED THAT A MODEL 325 PULSE GENERATOR WAS BEING RETURNED AFTER IT WAS UNABLE TO BE INTERROGATED. AN IPG TEST WAS PERFORMED AND THE DEVICE STILL HAD "NO OUTPUT." ON 11/1/96, THE CO RECEIVED THE DEVICE AND AN INVESTIGATION WAS CONDUCTED. THE SUBJECT DEVICE WAS IN THE POSSESSION OF THE CO SALES REP AS PART OF HIS SALES INVENTORY. SALES REP IS IDENTIFIED AS THE INITIAL RPTR.

    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 NA