BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2153443 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07507
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE PHYSICIAN'S OFFICE WITH COMPLAINTS OF THE ITCHING AT THE SITE OF IMPLANT. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS NOT PRESENT AT THE DEVICE CHECK AND STATED THAT THE PHYSICIAN ALLEGED A POSSIBLE POCKET EROSION. THE PATIENT TESTED POSITIVE FOR A SILICONE ALLERGY AND THE PHYSICIAN IS DECIDING ON A COURSE OF ACTION. THE SYSTEM CURRENTLY REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE CHANGE OUT PROCEDURE.

    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 54 YR Hospitalization| L| R 4135| 0184| E110