BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 6246218 · Received January 12, 2017

    Report

    Report Number
    2124215-2016-21611
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    September 19, 2016
    Report Date
    March 6, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWW
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THIS DEVICE WILL BE EXPLANTED AS THE PATIENT IS REFUSING TO UNDERGO AN EXPLANT PROCEDURE. AT THIS TIME, IT REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THIS ISSUE IS CURRENTLY ONGOING. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS REFUSING TO HAVE THE DEVICE EXPLANTED. ANOTHER MEMORY DOWNLOAD WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO EVALUATE THE CURRENT DEPLETION OF THE DEVICE. A TS CONSULTANT DISCUSSED THAT THE POWER CONSUMPTION CONTINUES TO REMAIN STABLE; HOWEVER, DEVICE EXPLANT WITHIN 28 DAYS WAS STILL RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS INFORMATION WAS TO BE PROVIDED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WENT TO THE HOSPITAL AFTER EXPERIENCING A LOSS OF CONSCIOUSNESS. INTERROGATION OF THE DEVICE REVEALED THAT THERE WERE NO EPISODES STORED AND THE ELECTRICAL PARAMETERS WERE IN AN ACCEPTABLE RANGE AND STABLE. IT WAS NOTED THAT THE DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS HOSPITALIZED FOR FURTHER TESTING IN THE NEPHROLOGY DEPARTMENT. ONCE TESTING IS COMPLETED, THE DEVICE WILL BE SCHEDULED FOR EXPLANT. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO A PRODUCT PERFORMANCE ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28364 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWW GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L F102