BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905380 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10847
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. IMPEDANCE MEASUREMENTS WERE NOTED TO HAVE INCREASED OVER THE COURSE OF APPROXIMATELY ONE YEAR PRIOR TO GOING OUT OF RANGE. THERE WAS A SLIGHT INCREASE IN RV PACING THRESHOLD. SENSING WAS STABLE AND NO EPISODES OF NOISE WERE RECORDED TO THE DEVICE. A REVISION PROCEDURE WAS PERFORMED WHEREIN BOTH THE DEVICE AND LEAD WERE REPLACED WITH THE ICD BEING EXPLANTED AND RV LEAD SURGICALLY ABANDONED. MEASUREMENTS ON THE NEW SYSTEM WITH WITHIN NORMAL LIMITS. THE PATIENT WAS REPORTED TO NOT BE PACEMAKER DEPENDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD AND RV LEAD ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382319 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F102| 0292| F140| 0175