BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1953768 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24271
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 17, 2007
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. NO DEVICE CHARACTERISTICS WERE IDENTIFIED DURING ANALYSIS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATION OF NOISE ON THE SHOCK CHANNEL

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THIS IMPLANTABLE DEFIBRILLATION LEAD RECEIVED A SHOCK. REVIEW OF THE ELECTROGRAM (EGM) REVEALED NOISE ON THE SHOCK CHANNEL. THE RESTING ELECTROGRAM (EGM) DID NOT REVEAL ANY NOISE, HOWEVER NOISE WAS RECREATED THROUGH ISOMETRICS. THE LOCAL AREA SALES REPRESENTATIVE STATED ANOTHER MANUFACTURER'S SUBQ-ARRAY WAS IMPLANTED WITH THIS LEAD AND IS LOCATED NEAR THE ATRIUM WHICH MAY LEAD TO MORE PRONOUNCED P-WAVES ON THE SHOCK CHANNEL. IT WAS ALSO REPORTED THAT THE PATIENT FOLLOWS-UP WITH THE CLINIC ONCE A MONTH TO RECEIVE SHOCK TO CONVERT OUT OF ATRIAL FIBRILLATION. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES (TS) CONSULTANT REVIEWED RHYTHM STRIPS FROM THE EPISODE AND NOTED THE PRONOUNCES P-WAVES ON THE SHOCK CHANNEL. TS EVALUATED THE LEAD DIAGNOSTICS AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. TS DISCUSSED THE LEADS MAY BE REVERSED IN THE HEADER, HOWEVER WITHOUT NOISE ON THE RATE/SENSE CHANNEL IT WAS DIFFICULT TO MAKE THAT CORRELATION. TS ALSO DISCUSSED POSSIBLE DAMAGE TO THE SUBQ-ARRAY WHICH MAY BE RESULTING IN THE OBSERVED NOISE. THE LOCAL AREA SALES REPRESENTATIVE REPORTED THAT NO ACTION WOULD BE TAKEN AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE DEVICE WAS EXPLANTED APPROXIMATELY THREE YEARS LATER. NO ALLEGATIONS WERE MADE AGAINST DEVICE FUNCTIONALITY AT THE TIME OF EXPLANT. INITIAL LABORATORY ANALYSIS FOUND THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0184| T167| MISMATCH| 4469