BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3212610 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10047
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS SUCCESSFULLY EXPLANTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED SCRATCHES ON THE CASE. ALL SEAL PLUGS WERE INTACT AND ALL SET SCREWS OPERATED NORMALLY. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN 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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD AND CHRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOSS OF CAPTURE (LOC) RESULTING IN PACING INHIBITION FOR GREATER THAN TWO SECONDS OF ASYSTOLE. THE PATIENT WAS PACEMAKER DEPENDENT. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE. DURING THE REPLACEMENT PROCEDURE, THE LEAD WAS CONNECTED TO A PACING SYSTEM ANALYZER (PSA) AND NORMAL PACING THRESHOLD MEASUREMENTS WERE OBSERVED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED AND THE CHRONIC LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE AND APPROPRIATE CAPTURE WAS OBSERVED. DURING A POST-OPERATIVE FOLLOW UP ONE DAY POST IMPLANT, PAUSES IN PACING FOR A DURATION OF THREE SECONDS WERE OBSERVED WITH THE CHRONIC LEAD AND REPLACEMENT DEVICE. ADDITIONALLY, REVIEW OF STORED DEVICE MEMORY REVEALED NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO NOISE AND OVERSENSING. THE NOISE APPEARED TO BE OCCURRING WHILE THE PATIENT WAS SITTING IN A CHAIR. THRESHOLD TESTING WAS PERFORMED AND NORMAL PACING THRESHOLD MEASUREMENTS AND CAPTURE WERE AGAIN OBSERVED AND WERE CONFIRMED SEVERAL TIMES WITH THE PATIENT COUGHING, TALKING AND SNORTING. NO NOISE OR PACING INHIBITION WAS ABLE TO BE PRODUCED DURING TESTING AND PACING IMPEDANCE MEASUREMENTS WERE CONFIRMED TO BE WITHIN NORMAL LIMITS. PROGRAMMING CHANGES WERE MADE, HOWEVER, LOC WAS AGAIN OBSERVED WITH PAUSES IN PACING FOR GREATER THAN FOUR SECONDS OF ASYSTOLE. SUBSEQUENTLY, THE CHRONIC IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE AND OVERSENSING RESULTING IN DELIVERY OF INAPPROPRIATE SHOCKS. ADDITIONALLY, THE PATIENT DEVELOPED AN INFECTION/SEPSIS. THE CAUSE AND SOURCE OF THE INFECTION WAS UNKNOWN. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314107 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 0185| T167| 7274| 6947| E163| 6940