BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1951508 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23017
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE IMPLANTED WITH A NON-BOSTON SCIENTIFIC LEAD DISPLAYED INCREASED IMPEDANCE MEASUREMENTS. FURTHER FOLLOW UP WAS PERFORMED. THE PATIENT RETURNED FOR A FOLLOW UP VISIT. AN X-RAY AND VISUAL OBSERVATION DID NOT REVEAL ANY ISSUES. A REVISION PROCEDURE WAS PERFORMED, THE LEAD WAS REMOVED AND REPLACED. NO ISSUES WERE REVEALED WITH THE LEAD. IT WAS THOUGHT THERE WAS AN ISSUE WITH THE CONNECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention