BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2914317 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00914
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A CHANGE-OUT PROCEDURE HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCES WERE OBTAINED WHEN PAINLESS COMMANDED IMPEDANCE TESTING WAS DONE ON THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. READINGS OF >125 OHMS IN THE TRIAD CONFIGURATION WERE OBTAINED, AND READINGS OF 119 AND >125 OHMS WERE OBSERVED WHEN THE RV COIL TO CAN AND COLD CAN MEASUREMENTS WERE TAKEN (THOUGH IT IS NOT KNOWN WHICH CONFIGURATION HAD WHAT READING). DEFIBRILLATION THRESHOLD (DFT) TESTING WAS DONE IN THE TRIAD CONFIGURATION AND AT 31J THE IMPEDANCE WAS 53 OHMS. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND POTENTIAL REASONS FOR THE VARYING MEASUREMENTS WERE PROVIDED. AT THIS TIME, BOTH THIS RV LEAD AND CRT-D REMAIN IN SERVICE AND THE PROGRAMMED SHOCK CONFIGURATION REMAINS TRIAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19682 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR N161| 4549| 4470| 0185| H217