BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1771650 · Received July 28, 2010

    Report

    Report Number
    2124215-2010-12157
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 25, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT LATITUDE DETECTED A RED ALERT FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO OUT OF RANGE RIGHT VENTRICULAR (RV) IMPEDANCES OF GREATER THAN 2000 OHMS. IT WAS NOTED THAT NOISE COULD BE PRODUCED WITH POCKET MANIPULATION. TECHNICAL SERVICES (TS) DISCUSSED PERFORMING AN X-RAY, AND THAT THIS COULD BE A LEAD PROBLEM OR CONNECTION ISSUE. IT WAS NOTED THAT THE PATIENT WAS NOT PACEMAKER DEPENDANT, AND THE NOISE WAS NOT BEING SENSED BY THE DEVICE. THE PLAN FOR THE PATIENT WAS TO ADMIT THEM AND POSSIBLY PERFORM A DEVICE/LEAD REVISION. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT IS A WEIGHTLIFTER. THERE WAS ANOTHER IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS, AND NOISE WAS ABLE TO BE CREATED WHEN PUSHING WHERE THE LEADS GO INTO THE HEADER. THERE WAS NO NOISE WHEN PUSHING AT THE BACK OF THE HEADER. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH A LOOSE CONNECTION WAS FOUND. THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND WAS THEN RE-ATTACHED TO THE DEVICE WITH NORMAL MEASUREMENTS. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE AND LEAD WERE CHECKED AGAIN SEVERAL TIMES WITH NORMAL RESULTS; THEREFORE, THE PHYSICIAN ELECTED TO LEAVE THE SYSTEM AS IS. THE PATIENT WILL CONTINUE TO BE MONITORED.

    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 79 YR Required Intervention A155| 4087| 0158| E110