BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACEMAKER LEADS

    MDR report key: 269839 · Received March 15, 2000

    Report

    Report Number
    269839
    Event Type
    Death
    Date Received
    March 15, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 13, 2000
    Manufacturer
    BIOTRONIK INC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DIED SUDDENLY AT HOME, UNEXPECTED CARDIAC DEATH. COULD NOT SATISFACTORILY IDENTIFY PACER SPIKES. QUESTIONS MALFUNCTIONS ON THE PERMANENT PACEMAKER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/12/00: ACTROS DR+, THE DEVICE WAS INTERROGATED AT BIOTRONIK, BERLIN ON JULY 4, 2000, WHICH REVEALED EXPECTED BATTERY VALUES. THE LAST FOLLOW-UP RECORDED WAS FEBRUARY 1, 2000. FROM THIS DATE UP TO JUNE 4, 2000 THERE WAS NO REPROGRAMMING INDICATING THAT DURING THIS TIME THE NIGHT PROGRAM OF THE PACEMAKER WAS NOT ACTIVATED. THIS IS SIGNIFICANT INSOFAR AS THE MEDWATCH REPORT OF JUNE 1, 2000 INDICATED THAT THE PT FELT UNCOMFORTABLE AT NIGHT, NOT DURING THE DAY. THE PACEMAKER WAS THEN SUBJECTED TO A COMPLETE FINAL ACCEPTANCE TEST AND IT PROVED TO BE WITHIN ALL ELECTRICAL SPECIFICATIONS. THERE IS NO INDICATION FOR A FAILURE OF PERMANENT OR INTERMITTENT NATURE. THE UNIT IS FULLY FUNCTIONAL. RX 45 JBIP, THE LEAD SHOWS A SMALL KINK ABOUT 5 CM FROM THE CONNECTOR. OTHERWISE THE LEAD IS FULLY WITHIN THE VISUAL INSPECTION CRITERIA. THERE IS NO DEFECT IN THE SILICONE INSULATION. THE PIN CONNECTOR DIMENSIONS ARE AS REQUESTED BY IS-1 STANDARDS. THE FIXATION HELIX IS FULLY FUNCTIONAL. THE LEAD TIP DOES NOT SHOW ANY DEVIATION FROM SPECIFICATIONS. THE DC RESISTANCES BETWEEN THE DIFFERENT TIP AND CONNECTOR POTENTIALS ARE AS SPECIFIED. THERE IS NO INDICATION FOR A PERMANENT OR INTERMITTENT CONTACT INTERRUPTION OR SHORT CIRCUIT BETWEEN THE LEADS. PX 53 BP, THE LEAD IS CUT IN TWO PIECES. THE CUT IS ABOUT 20 CM APART FROM THE TIP. THE DAMAGED AREA WAS VISUALLY INSPECTED AND IT SHOWS WITHOUT A DOUBT THAT THE CUT IS DONE ARBITRARILY BY A SURGICAL INSTRUMENT, PROBABLY UPON REMOVAL OF THE LEAD. APART FROM THE CUT, BOTH PIECES ARE WITHIN ALL VISUAL SPECIFICATIONS, INCLUDING THE DIMENSIONS OF THE LEAD CONNECTOR. THE LEAD RESISTANCES BETWEEN THE DIFFERENT TIP AND THE PIN POTENTIALS AND THE RESPECTIVE POTENTIAL AT THE CUT ZONE ARE AS EXPECTED. THE PACING SYSTEM CONSISTING OF THE PACEMAKER, ATRIAL LEAD AND VENTRICULAR LEAD IS NOT RELATED TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEMAKER LEADS LEAD DTB BIOTRONIK INC * *
    2 PACEMAKER LEADS LEAD DTB BIOTRONIK INC * *
    3 PACEMAKER GENERATOR GENERATOR DXY BIOTRONIK INC ACT ROS DR 122311 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death