BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911438 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17198
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 22, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT AND FAMILY MET WITH THE PHYSICIAN. OPTIONS WERE DISCUSSED, AND DUE TO THE PATIENT'S AGE, DEBILITATED HEALTH STATUS, AND DESIRE NOT TO PURSUE AGGRESSIVE TREATMENT, THE VENTRICULAR TACHY THERAPIES OF THE DEVICE WERE PROGRAMMED OFF. PACING THERAPY REMAINS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME REMOTE MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND TRENDING PLOT WAS REVIEWED. IT WAS NOTED THAT THE SHOCK LEAD IMPEDANCE WAS AROUND 100 OHMS THIS PAST SPRING AND EARLY SUMMER, AND THEN THE MEASUREMENTS WENT BACK DOWN; HOWEVER, IN FALL THE DATA POINTS WERE MISSING FOR APPROXIMATELY TWO MONTHS, AND THEN RECENT MEASUREMENTS WERE IN THE 70-80 OHMS RANGE, DIPPED TO THE 40-50 OHMS RANGE AND THEN WENT UP TO APPROXIMATELY 90-100 OHMS WITH FINALLY SEVERAL OOR MEASUREMENT BEING DETECTED RECENTLY. TS DISCUSSED EVALUATION OPTIONS. THE HEALTH CARE PROFESSIONAL (HCP) NOTED THAT THE PATIENT WAS BEING MONITORED MORE FREQUENTLY WITH THE REMOTE HOME MONITORING SYSTEM, AND HAS AN APPOINTMENT IN THE NEAR FUTURE TO SEE HIS PHYSICIAN. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18440 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR E102| 4574| A135| 0175| 0138| T165| 4086