BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211554 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09402
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A PERMANENT SYSTEM ONE WEEK LATER. 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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PATIENT WAS PACEMAKER DEPENDENT. THE PRODUCT WAS EXPLANTED AND PLACED EXTERNALLY AND A TEMPORARY LEAD WAS IMPLANTED FOR PACING SUPPORT WHILE THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308897 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 0185| 0154| 1851| 4017| 4136| E110| T125