BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041535 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32008
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    November 3, 2007
    Report Date
    September 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF >125 OHMS FOLLOWING AN UNRELATED LEAD REVISION PROCEDURE. OTHER RIGHT VENTRICULAR LEAD MEASUREMENTS WERE NORMAL. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED A POTENTIAL LOOSE SETSCREW OR LEAD FRACTURE, AND RECOMMENDED PERFORMING A MINIMUM AND MAXIMUM ENERGY SHOCK TO TEST THE SYSTEM. IT WAS LATER REPORTED THAT THE POCKET WAS OPENED AGAIN TO CORRECT THE HIGH VOLTAGE LEADS BEING REVERSED IN THE HEADER. AFTER THIS WAS COMPLETE, THE SHOCKING LEAD IMPEDANCE RANGED FROM 52 OHMS TO 69 OHMS. HOWEVER, A RED ALERT WAS ISSUED FOR A SHOCK IMPEDANCE OF >125 OHMS. THE PATIENT WAS SEEN IN THE CLINIC, AND THE CLINICAL EVENT WAS CLEARED IN THE DEVICE. SHOCK LEAD IMPEDANCE TESTS (SLIT) WERE PERFORMED, WITH NO OUT OF RANGE MEASUREMENTS SEEN. THE NEXT DAY, ANOTHER RED ALERT WAS ISSUED FOR >125 OHMS SHOCK IMPEDANCE. TS DISCUSSED DELIVERING A MIN. AND MAX. ENERGY SHOCK TO VERIFY LEAD INTEGRITY. THE PATIENT WAS SEEN AGAIN AND A 41 J SHOCK WAS DELIVERED. THIS PRODUCED AN IMPEDANCE OF 40 OHMS. NO NOISE COULD BE PRODUCED WITH POCKET MANIPULATION, AND REPEATED SLITS RESULTED IN ACCEPTABLE MEASUREMENTS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE SHOCK LEAD IMPEDANCE. SUBSEQUENT INFORMATION STATED THAT SHOCKING IMPEDANCES WERE AGAIN GREATER THAN 125 OHMS. THE IMPEDANCES HAVE BEEN INTERMITTENT AND HAVE NOT BEEN RESOLVED. THE PHYSICIAN PLANS TO BRING THE PATIENT IN EVERY 6 MONTHS TO TEST SHOCK SYSTEM WITH MAX SHOCK ENERGY. SUBSEQUENT INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A LEAD REVISION PROCEDURE TO HAVE A COMPETITOR'S RV LEAD PLACED. UPON ATTEMPT TO LOOSE THE SETSCREWS, IT WAS DETERMINED THAT THE SETSCREW WAS STUCK; THEREFORE THE PHYSICIAN ALSO REPLACED THE ICD ALONG WITH THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention THE DEVICE H217/ WAS IMPLANTED| THE DEVICE H217/712247 WAS IMPLANTED 01-NOV-2007| THE DEVICE 4470/558082 WAS IMPLANTED 01-NOV-2007| THE DEVICE 4555/159274 WAS IMPLANTED 01-NOV-2007