BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3052546 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03805
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING AN IMPLANT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH SHOCK IMPEDANCE GREATER THAN 200 OHMS. DURING LEAD INTEGRITY TESTING ALL MEASUREMENTS WHERE WITHIN RANGE; HOWEVER, THE SHOCK IMPEDANCES REMAINED HIGH. THE PHYSICIAN MADE THE DECISION TO INDUCE THE PATIENT AND THE ARRYTHMIA WAS SUCCESSFULLY STOPPED WITH 21 JOULES. SHOCK IMPEDANCES WERE NOW AT 69 OHMS AND WITHIN RANGE; HOWEVER WHEN MEASUREMENTS WERE TAKEN WITH THE DEVICE IMPEDANCES REMAINED ABOVE 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (T'S) WAS CONTACTED. ALL EXTERNAL PRODUCTS WERE REMOVED FROM THE ROOM AND DEVICE CIRCUITS WERE SWITCH OUT AND THE MEASUREMENTS REMAINED HIGH. TS RECOMMENDED A DEVICE CHANGE OUT. THE DEVICE AND LEAD WERE REMOVED AND REPLACED. MEASUREMENTS STAYED ABOVE 200 OHMS WITH THE NEW DEVICE AND LEAD. THE PHYSICIAN AND FIELD REPRESENTATIVE REALIZED THAT THE DEVICE HAD NOT BEEN PROGRAMMED OUT OF THE TRIAD CONFIGURATION INSTEAD OF IN THE SINGLE COIL CONFIGURATION. THE PROBLEM HAD BEEN RESOLVED AND THE HIGH IMPEDANCE MEASUREMENTS WERE DUE TO A PROGRAMMING ERROR MADE BY THE PHYSICIAN. THE FIRST DEVICE AND LEAD WERE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156343 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F162

    Patients

    Seq Age Sex Outcome Treatment
    1