BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1771305 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12287
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION. A REQUEST HAS BEEN MADE TO HAVE THESE PRODUCT RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO AN INFECTION. EXPLANTED PRODUCTS INCLUDED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), TRANSVENOUS RIGHT VENTRICULAR (RV) RATE/SENSE AND DEFIBRILLATION LEADS, AND A TRANSVENOUS RIGHT ATRIAL (RA) LEAD.

    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 68 YR Life Threatening| R 0158| 4035| E110| 4469| 1298| A155