BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173141 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10500
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) CHANNEL WITH A NON- BOSTON SCIENTIFIC RA LEAD. THE PHYSICIAN REMOVED THE DEVICE AND CONFIRMED THE LEAD WAS SECURE IN THE HEADER, WHICH IT WAS NOTED TO BE SECURE. THE PHYSICIANL UNSCREWED THE SETSCREW, REMOVED THE TERMINAL PIN, AND REINSTERD. NO FURTHER NOISE WAS NOTED. 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 74 YR 1861| E110| 0185| 5076