BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4132310 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14667
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WITH THIS DEVICE REPORTED THAT THE DEVICE EMITTED BEEPING TONES. UPON DEVICE INTERROGATION, THE DEVICE DISPLAYED A FAULT CODE, INDICATING VOLTAGE TOO LOW FOR REMAINING PROJECTED CAPACITY. TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT, INCLUDING DEVICE EVALUATION. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED AND WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613199 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R E110| 0180| 4473