BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRONIK

    MDR report key: 277160 · Received May 10, 2000

    Report

    Report Number
    MW1018849
    Event Type
    Death
    Date Received
    May 10, 2000
    Date of Event
    March 8, 2000
    Report Date
    May 10, 2000
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD A PACEMAKER INSERTED IN 1999. SINCE THAT TIME PT HAD SIGNIFICANT SWELLING ABOUT THE PACEMAKER SITE AND EXTREME SWELLING IN LEGS. PT COULD NOT SLEEP LAYING DOWN. DEATH OCCURRED ON 3/8/2000. ATTENDING PHYSICIAN NOTED NO PACEMAKER ACTIVITY ON EKG RECORDING FROM PARAMEDIC EQUIPMENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/12/00: 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 SPECS. 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. 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 PACEMAKER DXY BIOTRONIK, INC. ACTROS DR + *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death