BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2053481 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04047
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN 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

    FURTHER INFORMATION PROVIDED NOTE THAT THE SHOCK LEAD IMPEDANCES HAVE BEEN OCCASIONALLY GREATER THAN 125 OHMS. A RECENT MEASUREMENT WAS 76 OHMS WHEN PROGRAMMED TO TRIAD. NO NOISE WAS PRESENT WITH MANEUVERS. WHILE PROGRAMMED IN THE COIL TO CAN CONFIGURATION THE IMPEDANCES MEASURED 82-85 OHMS. HOWEVER, IN THE COIL TO COIL CONFIGURATION IMPEDANCES WERE CONSISTENTLY GREATER THAN 125 OHMS. TECHNICAL SERVICES DISCUSSED POSSIBLE ISSUES AND RECOMMENDED FURTHER DISCUSSION WITH THE PHYSICIAN AS FURTHER TESTING MAY BE WARRANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RESOLUTION HAS BEEN REQUESTED FROM THE REPRESENTATIVE. HOWEVER, TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED BY THE FIELD REPRESENTATIVE THAT THIS PATIENT UNDERWENT DEFIBRILLATION THRESHOLD TESTING IN THE COIL TO CAN CONFIGURATION WHICH RESULTED IN SUCCESSFUL DEFIBRILLATION. THIS CONFIGURATION REMAINED AND THE PATIENT WAS SENT HOME AND WILL BE MONITORED ON A ROUTINE SCHEDULE. 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 UPON INTERROGATION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) NOTED TO CHECK THE SHOCK LEAD. ALL MEASUREMENTS WERE WITHIN NORMAL RANGE AND 50-90 OHMS ON THE LEAD IMPEDANCE TESTS. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R T165| 4054| 1851| 0154| E110