BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRONIK ACTROS DR+

    MDR report key: 280249 · Received May 31, 2000

    Report

    Report Number
    MW1019029
    Event Type
    Death
    Date Received
    May 31, 2000
    Date of Event
    March 8, 2000
    Report Date
    May 23, 2000
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT COULD NOT SLEEP, FELT VERY UNCOMFORTABLE. COULD WORK ALL DAY AND PLAY SHUFFLE-BOARD IN THE EVENING WITH NO DISCOMFORT. THE DR TOLD PT THEY WOULD GET USED TO IT. AT NIGHT PT WOULD SIT UP AND RUB THEIR CHEST AND SHOULDER. PT SAID WHEN THEY LAID DOWN THEY COULD FEEL THE PACEMAKER KICK IN. DR SAID PT WAS WRONG, THE PACEMAKER HAD KICKED IN ONLY 15 TIMES. PT HAD A TEST IN 2/2000, THE DR SAID THE PT WAS OK. THE TESTS WERE SONOGRAM, X-RAYS AND POTASSIUM. PT DIED IN THEIR SLEEP (SITTING UP). THE PARAMEDICS DID CARDIOGRAM WHICH SHOWED NO PEAKS. THEY SAID THE PACEMAKER DID NOT KICK IN. PT WAS A VERY ACTIVE PERSON WHO WORKED EVERY DAY WITH NO PROBLEM. THE NIGHTS WERE A NIGHTMARE SINCE THE PACEMAKER WAS PUT IN. PT NEVER HAD TROUBLE SLEEPING BEFORE.

    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 7/4/2000, WHICH REVEALED EXPECTED BATTERY VALUES. THE LAST FOLLOW-UP RECORDED WAS 2/1/2000. FROM THIS DATE UP TO 6/4/2000 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 6/1/2000 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 SPECS. THERE IS NO INDICATION FOR A FAILURE OF PERMANENT OR INTERMITTENT NATURE. THE UNIT IS FULLY FUNCTIONAL. 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 BIOTRONIK ACTROS DR+ PACEMAKER DXY BIOTRONIK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death