BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3210811 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07206
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 A CORED OUT HOLE IN THE RV SEAL PLUG. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED AND FOUND THE DEVICE TO BE AT BEGINNING OF LIFE (BOL) WITH 3.096 VOLTS. 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. THE DEVICE WAS FOUND TO HAVE A CORED OUT HOLE IN THE RV SEAL PLUG, WHICH IS KNOWN TO CONTRIBUTE TO NOISE AND OVER-SENSING.

    Additional Manufacturer Narrative · 1

    TO DATE THE EXPLANTED DEVICE AND LEAD HAVE NOT EEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE PRODUCTS WILL UNDERGO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, WHILE PERFORMING DEVICE TESTING THIS RIGHT VENTRICULAR (RV) LEAD REVEALED NOISE AND OVERSENSING. THE LEAD WAS THEN UNSCREWED FROM THE DEVICE AND RECONNECTED HOWEVER NOISE AND OVERSENSING CONTINUED TO OCCUR. THE LEAD WAS REPOSITIONED AND REMAIN OUT OF RANGE. THE LEAD WAS THEN EXPLANTED AND REPLACED,HOWEVER THE NEW LEAD REVEALED MANY NOISE AS WELL. THE FINAL DECISION WAS MADE TO REPLACED THE DEVICE. UPON VISUAL INSPECTION OF THE DEVICE THE SET SCREW SEALINGS APPEARED TO BE DEFECTIVE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT WAS CONTACTED. THE DEVICE AND LEAD WERE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310711 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R