BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 1382779 · Received February 10, 2009

    Report

    Report Number
    2124215-2008-01785
    Date Received
    February 10, 2009
    Report Date
    October 8, 2010
    Product Code
    LWS
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE DEVICE REACHED ERI AGAIN WITH A BV OF 2.65 V AND CT OF 18.4 SEC. MCR WERE PERFORMED AND THE DEVICE IS AGAIN NO LONGER AT ERI. TS STATED IT WAS HARD TO DETERMINE WHETHER THAT CHANGE IN BV WAS ABNORMAL. THE BATTERY CURVE WAS NOT LINEAR AND MCR DO PULL ENERGY. THE PHYSICIAN WAS TRYING TO GET MAXIMUM USE OF THE DEVICE. TS DISCUSSED THE MID LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND THAT WE DO NOT RECOMMEND DOING MULTIPLE MCR. THEY WILL CONTINUE TO MONITOR THE PATIENT FOR NOW. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THE DEVICE WAS LATER EXPLANTED FOR AN UNKNOWN REASON. THE DEVICE HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS DUE TO EXTENDED CHARGE TIME (CT). THE DEVICE WAS PART OF THE MID LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION. CHARGE TIME WAS 23 TO 28 SECONDS (SEC). THE PHYSICIAN DID SEVERAL MANUAL CAPACITOR REFORMS (MCR) AND CT WENT AS LOW AS 17 SECONDS AND THE BATTERY STATUS REVERTED TO MIDDLE OF LIFE 2. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT ONCE THE DEVICE REACHES ERI THAT WE RECOMMENDED DEVICE REPLACEMENT WITHIN THREE MONTHS OR TEN MAXIMUM ENERGY SHOCKS. THE PHYSICIAN PLANNED TO MONITOR THE BATTERY VOLTAGE (BV) VIA LATITUDE. IT WAS LATER REPORTED THAT CT WAS DOWN TO 15.6 SEC. TS DISCUSSED DEVICE REPLACEMENT DUE TO ERI BUT MAY CONTINUE TO MONITOR IF THE PHYSICIAN IS COMFORTABLE WITH THIS APPROACH. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS

    Patients

    Seq Age Sex Outcome Treatment
    1