BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 4140019 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17081
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 1, 2014
    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

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED, SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS FROM 90 TO 140 OHMS IN ADDITION TO INCREASED PACING THRESHOLDS. IT WAS NOTED THAT THE PATIENT FELT THERE WAS MORE ROOM IN THE DEVICE POCKET SINCE THEIR LAST REPLACEMENT AND THAT THEY HAD UNDERGONE AN ABLATION PROCEDURE APPROXIMATELY 9 MONTHS PRIOR. AN X-RAY WAS OBTAINED AND FOUND UNREMARKABLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED POSSIBLE CAUSES AND ADVISED PERFORMING ADDITIONAL TESTING. THE PATIENT IS SCHEDULED TO PRESENT FOR FOLLOW UP AT WHICH TIME FURTHER TESTS WILL BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS PATIENT PRESENTED FOR FOLLOW-UP AS PLANNED. PRIOR TO TESTING SHOCK IMPEDANCE MEASUREMENTS REMAINED HIGH AT 141 OHMS. THE SYSTEM WAS THEN TESTED USING SYNCHRONOUS SHOCKS AS WELL AS VENTRICULAR FIBRILLATION (VF) INDUCTION IN WHICH NORMAL IN-RANGE VALUES WERE RETURNED AND THE SYSTEM SUCCESSFULLY CARDIOVERTED THE PATIENT. THE PHYSICIAN WAS CONFIDENT THAT ANY EPISODES OF VR WOULD BE CONVERTED SUCCESSFULLY EVEN IN THE PRESENCE OF HIGH SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WILL BE CLOSELY MONITORED REMOTELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619634 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F161

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 0181| F161