BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT

    MDR report key: 1002169 · Received January 29, 2008

    Report

    Report Number
    1002169
    Event Type
    Injury
    Date Received
    January 29, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SEEN AT THE PACEMAKER CLINIC AS A FOLLOW UP INTERROGATION WITH COMPLAINTS OF VIBRATIONS AROUND HIS PACEMAKER AND HE CONTINUED SHORTNESS OF BREATH. HE WAS PREVIOUSLY NOTED TO HAVE NOISE ON HIS V LEAD WITH DEDICATED UNIPOLAR LEAD. HIS THRESHOLDS ARE SATISFACTORY. LEAD IMPEDANCE IS STABLE. THERE ARE MULTIPLE TACHY EPISODES. REVIEW OF STORED EGM SHOWED NOISE ON THE V LEAD WITH SOME INHIBITION OF PACING. THE PATIENT DENIED ANY COMPLAINTS OF BEING LIGHT HEADED OR DIZZINESS. HE WAS REPROGRAMMED VOOR SO THAT THE DEVICE WOULD NOT INHIBIT PACING DUE TO NOISE ON LEAD IN A PACEMAKER-DEPENDENT PATIENT. THIS IS A DEVICE RECALL. IT IS A FAILURE MODE 2 WITH NORMAL MONITORING. NO ADVISORIES FOR RECALL ON THE LEAD OF THE RV. THE PATIENT INITIALLY HAD HIS PACEMAKER PLACED FOR THIRD-DEGREE HEART BLOCK 15 YEARS AGO. HE HAD HIS BATTERY CHANGED SEVERAL YEARS AGO. AT THAT TIME HE HAD CAPPING OF AN OLD ATRIAL LEAD. PATIENT ADMITTED FOR REPLACE OF PACER AND UPGRADE TO DUAL CHAMBER DEVICE. THE VENTRICULAR LEAD IS AN ELA, MODEL #T84F. BECAUSE OF MAL SENSING, THE LEAD WAS CAPPED AND PLACED BACK INTO THE POCKET. THE PATIENT HAD A NEW PACER AND LEADS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT PACEMAKER DXY BOSTON SCIENTIFIC 1190 *
    2 ELA LEAD, PACEMAKER DTB BOSTON SCIENTIFIC T84F *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CARDIAC DRUGS| CARDIAC DRUGS