BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3101866 · Received May 3, 2013

    Report

    Report Number
    3009448963-2013-00053
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCUSSED TO INTENSIFY PT FOLLOW-UPS TO CONTINUE MONITORING THE DEPLETION UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI) IS REACHED. CURRENTLY, THE DEVICE REMAINS IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED AN ERROR MESSAGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. IT WAS NOTED THAT THE ERROR WAS A BATTERY DEPLETION (BD) ERROR INDICATING THAT THE RATE OF DEPLETION IS HIGHER THAN EXPECTED. THE TS CONSULTANT SAID TO RESET THE BEEPER AND SUBMIT A MEMORY DOWNLOAD FOR EVAL. THE DATA REVIEW REVEALED THAT THE DEVICE WAS OPERATING PROPERLY. THE BD ERROR WAS TRIGGERED SHORTLY AFTER A NORMAL AUTOMATIC CAPACITOR REFORMATION OCCURRED AT 7 SECONDS. THE BATTERY PERCENTAGE IS CURRENTLY 67%. THE DEVICE INTEGRITY CHECK FOR THE BATTERY VOLTAGE TRIGGERED THE ALERT, BUT A DETAILED REVIEW OF THE AVAILABLE DIAGNOSTIC INFORMATION CONFIRMED THAT THE BATTERY IS DEPLETING NORMALLY. THE TS CONSULTANT DISCUSSED THAT THE BEEPER SHOULD BE RESET. IT WAS ALSO DISCUSSED THAT THE RED WARNING SCREEN CANNOT BE RESET AT THIS TIME AND WILL CONTINUE TO BE DISPLAYED AT EACH INTERROGATION. NO ADVERSE PT EFFECTS WERE REPORTED. TWO MONTHS LATER, THE PT WENT TO THE CLINIC AFTER HEARING TONES BEING EMITTED FROM THE DEVICE. A REVIEW OF THE MEMORY REVEALED THAT THE BATTERY STATUS WAS NOW AT 34%. THERE IS A CONCERN THAT THE BATTERY IS DEPLETING FASTER THAN EXPECTED. A MEMORY DOWNLOAD WAS SUBMITTED. A COMPANY ENGINEER REVIEWED THE DATA AND CONFIRMED THAT THE DEVICE BATTERY IS DEPLETING PREMATURELY. THE ESTIMATED REMAINING LONGEVITY WITH THE CURRENT DATA WAS UP TO 5 MONTHS. THE NEXT SCHEDULED BATTERY MEASUREMENT WILL BE PERFORMED LATER THIS MONTH AND IT WAS DISCUSSED TO PERFORM ANOTHER MEMORY DOWNLOAD TO OBTAIN A MORE ACCURATE ESTIMATED LONGEVITY. ANOTHER MEMORY DOWNLOAD WAS PERFORMED IN APRIL AFTER THE LAST BATTERY MEASUREMENT WAS TAKEN. ALTHOUGH THE RATE OF DEPLETION IS NOT AS FAST AS EARLIER OBSERVED, IT WAS DISCUSSED THAT THE DEPLETION RATE IS STILL NOT LINEAR AND THE BATTERY IS EXPERIENCING PREMATURE DEPLETION. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194989 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1