BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN DUAL CHAMBER ICD

    MDR report key: 1950750 · Received December 30, 2010

    Report

    Report Number
    MW5018793
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH HISTORY OF CAD, S/P CABB, ISCHEMIC MYOPATHY, S/P DUAL CHAMBER ICD PLACEMENT (B)(6) 2010 FOR PRIMARY PREVENTION. WHEN PT SEEN IN DEVICE CLINIC FOR FOLLOW UP, IT WAS FOUND THE DEVICE WAS NOT COMMUNICATING WITH THE PROGRAMMER EITHER THROUGH RF NOR WITH WAND. TECH SERVICES SUGGESTED, IT COULD BE COMPLETE DRAIN OF BATTERY, THE PT WAS ADMITTED AND UNDERWENT A GENERATOR REPLACEMENT. AFTER REMOVING THE INITIAL DEVICE FROM THE POCKET, IT STILL COULD NOT BE INTERROGATED WITH THE WAND INDICATING THAT IT FAILED PREMATURELY AND WITHOUT WARNING. DIAGNOSIS OR REASON FOR USE: PRIMARY PREVENTION OF SCD SECOND TO ISCHEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN DUAL CHAMBER ICD ICD LWS BOSTON SCIENTIFIC E110 139588

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability