BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 5186740 · Received October 29, 2015

    Report

    Report Number
    2124215-2015-12957
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    September 28, 2015
    Report Date
    December 3, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE RE-EVALUATED WHEN ADDITIONAL DETAILS ARE RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ANALYSIS OF THE DEVICE MEMORY CONFIRMED THAT THE DEVICE HAD SHOCKED INTO A SHORTED LEAD, DAMAGING THE DEVICE. IT IS CONCLUDED THAT THE DAMAGE TO THE DEVICE WAS INDUCED AS IT WAS THE RESULT OF SHOCKING INTO A SHORTED LEAD CONDITION. 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 THIS PATIENT THOUGHT HE HAS RECEIVED A SHOCK AND WAS IN THE HOSPITAL. NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL WHICH HAD BEEN OVERSENSED AND CAUSED A SHOCK TO BE DELIVERED. IT WAS DISCOVERED THAT THE COMPETITIVE RV LEAD WAS FRACTURED. DEVICE INTERROGATION REVEALED A FAULT CODE (FC) (B)(4)DUE TO A SHORTED LEAD CONDITION. A REVISION PROCEDURE WAS PERFORMED AND THE SYSTEM WAS REMOVED FROM SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719486 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R JT45