BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1871046 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17087
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THIS DEVICE UNDERWENT HIGH MAGNIFICATION VISUAL INSPECTION, DURING WHICH, THE PRESENCE OF MARKS FROM SEAL PLUG RINGS WERE NOTED; CONSISTENT WITH FULLY INSERTED LEADS. PROPER ADHESION OF THE HEADER TO THE DEVICE CASE WAS ALSO OBSERVED. X-RAY INSPECTION OF THE DEVICE HEADER CONFIRMED PROPER CONNECTION BETWEEN THE FEED THROUGH AND TERMINAL PORTS. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. NO BODILY FLUID OR CONDENSATION CONTAMINATION WAS NOTED IN THE CLINICALLY OBSERVED DISTAL COIL PORT AND PROXIMAL PORTS; HOWEVER, THERE WAS EVIDENCE OF BODILY FLUID INSIDE THE RIGHT ATRIAL (RA) PORT. PRESENCE OF BODILY FLUID IN THIS PORT WOULD NOT HAVE CONTRIBUTED TO THE OUT OF RANGE SHOCK IMPEDANCES.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    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 SHOCK IMPEDANCES OF GREATER THAN 125 OHMS. IT WAS NOTED THAT IT HAD BEEN STEADILY RISING OVER TIME. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, SHOCK IMPEDANCES WERE NORMAL. IT WAS NOTED THAT CONDENSATION WAS OBSERVED INSIDE THE DISTAL COIL PORT, AND BLOOD IN THE PROXIMAL PORT OF THE DEVICE HEADER. IT WAS NOTED THAT THE PATIENT'S DEFIBRILLATION LEAD LOOKED NORMAL VIA FLUOROSCOPY, AND MEASUREMENTS WITH THE LEAD WERE NORMAL WITH THE PACING SYSTEM ANALYZER (PSA). THE PHYSICIAN REQUESTED A NEW DEVICE. TECHNICAL SERVICES (TS) NOTED IT WAS PHYSICIAN DISCRETION TO TRY A NEW DEVICE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE DECISION WAS MADE TO EXPLANT AND REPLACE THIS DEVICE.

    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 53 YR Life Threatening| R 4087| 1788| 0144| H179| 1850| E110