BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904823 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09757
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS SYSTEM WAS EXPLANTED DUE TO A LOCALIZED INFECTION AROUND THE PATIENT'S ARMPIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO DETAILS PROVIDED ON A REPLACEMENT SYSTEM AND NO RETURN OF PRODUCT IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382380 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R F102| 0185