BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2052002 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03976
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. PER THE LOCAL AREA SALES REPRESENTATIVE, THIS PATIENT HAS A CHRONICALLY HIGH SHOCK IMPEDANCE IN THE LOW 100'S. THE PHYSICIAN DECIDED TO DO A MAX ENERGY SHOCK AND THE OUTCOME WAS SUCCESSFUL. ALL RESULTS WERE WITHIN NORMAL LIMITS. IF NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE TRANSVENOUS DEFIBRILLATION LEAD IN ASSOCIATION WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), DID EXHIBIT GREATER THAN 125 OHMS SHOCK IMPEDANCE. PREVIOUSLY, SHOCK IMPEDANCE HAD BEEN AROUND 100 OHMS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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 59 YR Life Threatening| R 4469| E110| 0180