BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911455 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16126
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    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 A RECENT DEVICE IMPLANT PROCEDURE, AFTER CONNECTING THE RIGHT VENTRICULAR LEAD TO THIS DEVICE, SLIGHTLY HIGHER THAN NORMAL IMPEDANCE LEVELS WERE NOTED ALONG WITH SOME OVERSENSED NOISE. SOME OF THE NOISE WAS SUSPECTED TO BE DUE TO POSSIBLE AIR BUBBLES IN THE DEVICE HEADER. THE RV LEAD WAS REMOVED, CLEANED, AND RE-CONNECTED, WITH SIMILAR DIAGNOSTICS, HOWEVER THE NOISE HAD DISSIPATED. THE PHYSICIAN DECIDED TO SUTURE THE POCKET, HOWEVER UPON DOING SO THE NOISE AND OVERSENSING APPEARED AT AN EVEN HIGHER FREQUENCY. THE LEAD WAS THEREFORE RE-POSITIONED WHICH ONCE AGAIN ELIMINATED THE NOISE, HOWEVER THE HIGH IMPEDANCE LEVELS CONTINUED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND LEAVE THE PRODUCTS IMPLANTED AND IN SERVICE DESPITE ONGOING HIGH IMPEDANCE LEVELS GREATER THAN 2000 OHMS. AT THIS TIME, NO FURTHER REMEDIAL ACTION HAS BEEN PLANNED OR TAKEN, AND BOTH THE DEVICE AND LEAD REMAIN IMPLANTED AND IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18444 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F111

    Patients

    Seq Age Sex Outcome Treatment
    1