BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2914247 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00911
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    May 24, 2012
    Report Date
    December 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS NEW DEVICE AND THE PATIENT'S CHRONIC RIGHT VENTRICULAR LEAD (COMPETITOR'S LEAD) EXHIBITED HIGH SHOCK LEAD IMPEDANCE READINGS GREATER THAN 125 OHMS. DIFFERENT VECTORS WERE EVALUATED AND RV COIL TO CAN MEASURED 60 OHMS, WHILE THE OTHER SHOCK VECTORS WERE OUT-OF-RANGE (OOR). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL CAUSES FOR THE OBSERVATION, AND SO THE CONNECTIONS WERE RECHECKED AND NOTED TO BE FINE. THE PHYSICIAN THEN SWITCHED THE HIGH VOLTAGE PINS IN THE HEADER, AND THE RV COIL TO CAN MEASUREMENT THEN MEASURED GREATER THAN 125 OHMS, SO THE PHYSICIAN SUSPECTED AN ISSUE WITH THE SVC COIL OF THE COMPETITOR'S LEAD, AND NOT A HEADER ISSUE. THOUGH THIS LEAD'S MEASUREMENTS ON THE OLD COMPETITOR'S DEVICE WERE NORMAL; TS DISCUSSED THAT THIS NEW DEVICE'S MEASUREMENTS WERE MORE SENSITIVE THAN PREVIOUSLY. THE LEADS WERE THEN RECONNECTED IN THE APPROPRIATE PORTS AND THE DEVICE WAS PROGRAMMED WITH A RV COIL TO CAN SHOCK CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20796 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1