BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3052567 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03742
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS VERIFIED THE DEVICE HAD A DEPLETED BATTERY AND NO TELEMETRY COULD BE ESTABLISHED. VISUAL INSPECTION OF THE DEVICE REVEALED DENTS AND ELECTROCAUTERY MARKS ON THE CASING. THE DEVICE CASE WAS REMOVED. ANALYSIS DETERMINED THERE WAS ELECTRICAL OVERSTRESS ON MULTIPLE PROTECTION COMPONENTS OF THE DEVICE WHICH RESULTED IN THE DEPLETED BATTERY AND NO DEVICE COMMUNICATION. ANALYSIS DETERMINED THAT DUE TO THE DENTS AND ELECTROCAUTERY MARKS, THIS WAS CONSISTENT WITH THE USE OF ELECTROCAUTERY AND LIKELY OCCURRED DURING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155196 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1