BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1945035 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21722
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT IN CLINIC FOR A THOROUGH DEVICE INTERROGATION, WHICH FOUND NOTHING ABNORMAL. IMPEDANCE MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE WHEN THE DEVICE WAS INTERROGATED. SUBSEQUENTLY, SEVERAL ADDITIONAL HIGH IMPEDANCE MEASUREMENTS WERE NOTED, AND THE PHYSICIAN ELECTED TO PERFORM SURGICAL INTERVENTION. THE POCKET WAS REOPENED, AND THE PHYSICIAN FOUND THAT THE RV LEAD TERMINAL PIN WAS NOT FULLY INSERTED INTO THE DEVICE HEADER. THE RV LEAD WAS SUCCESSFULLY RECONNECTED AND THE POCKET WAS CLOSED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A SINGLE RV PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS, TRIGGERING A LATITUDE RED ALERT. THE POSSIBILITY OF A RV CONNECTION ISSUE OR COMPROMISED RV LEAD WAS DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R 4469| 0185| E110