BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VITALITY

    MDR report key: 3123631 · Received May 9, 2013

    Report

    Report Number
    3123631
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTES FROM THE CARDIAC CONSULTATION: "ON RECENT DEVICE INTERROGATION IN THE OFFICE OF THE ELECTROPHYSIOLOGIST, THE PATIENT WAS FOUND TO HAVE NOISE ON THE LEAD WITH ELEVATED IMPEDANCE OF GREATER THAN 2500 OHMS. THE PATIENT HAS NOT RECEIVED ANY INAPPROPRIATE SHOCKS, BUT THE PATIENT WAS URGENTLY THEN SCHEDULED FOR LEAD REPLACEMENT SURGERY...THE PATIENT'S ICD GENERATOR HAS BATTERY DEPLETION AND WILL NEED REPLACEMENT WITHIN TWO YEARS. FOR THIS REASON, THE GENERATOR WILL BE PLACED AT THE TIME OF THE SURGERY. WE WILL PLAN LEAD EXTRACTION OF BOTH THE ICD ELECTRODES CURRENTLY IN PLACE FOR THIS VVI DEVICE. A NEW ICD ELECTRODE WILL BE IMPLANTED." NOTES FROM THE DISCHARGE SUMMARY: "THE PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE THE PREVIOUS TWO DUAL COIL ELECTRODES WERE EXTRACTED WITH SOME DIFFICULTY. THE LEADS WERE INTERMITTENTLY ASSOCIATED ONE WITH ANOTHER AND THERE WAS BLEEDING FROM THE INSERTION SITES REQUIRING TRANSFUSION. THE OLDEST LEAD, BEING MORE THAN 18 YEARS OF AGE, BROKE NEAR THE MID PORTION OF THE DISTAL COIL AND THEN WAS RETAINED INTRACARDIAC BUT FIRMLY ATTACHED TO THE ENDOCARDIUM. A NEW LEAD WAS PLACED WITHOUT DIFFICULTY." THE PATIENT TOLERATED THE PROCEDURE WELL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ICD GENERATOR EXPLANT; ICD GENERATOR IMPLANT.LASER LEAD EXTRACTION TIMES 2.IMPLANT DUAL COIL ICD ELECTRODE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202719 GUIDANT VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC T175VR *
    202819 GUIDANT ENDOTAK RELIANCE G LEAD LWS BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR