BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SERIES 200 PULSE GENERATOR

    MDR report key: 116707 · Received August 19, 1997

    Report

    Report Number
    2522457-1997-00011
    Event Type
    Injury
    Date Received
    August 19, 1997
    Date of Event
    July 20, 1997
    Report Date
    July 21, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 7/19/97, A 69 Y/O MALE PT WAS IMPLANTED WITH A BIPOLAR SINGLE-CHAMBER PACEMAKER AND ANOTHER MFR'S LEAD. ON 7/20/97, PT PRESENTED WITH LOSS OF CAPTURE. PHYSICIAN SAID HE OBTAINED GOOD LEAD THRESHOLDS BUT WAS UNSURE IF THE PACEMAKER HAD PACED ADEQUATELY FROM INITIAL HOOK-UP. PHYSICIAN ATTEMPTED TO REPROGRAM THE DEVICE BUT WAS UNSUCCESSFUL. PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND LEAD AND REPLACE IT WITH ANOTHER PACEMAKER AND LEAD FROM THE MFR. COMPLICATION WAS RESOLVED. A DEVICE EXPLANT/EVENT REPORT FORM WAS RECEIVED WHICH INDICATED BATTERY DEPLETION.

    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. 232 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization