BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041527 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01140
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    October 11, 2007
    Report Date
    February 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS BROUGHT BACK IN FOR DEFIBRILLATION THRESHOLD (DFT) TESTING. THE DFT TESTING WAS NOTED TO BE SUCCESSFUL, AND RESULTED IN SHOCK IMPEDANCES IN THE 90 OHM RANGE. THE PHYSICIAN HAD ELECTED TO TURN OFF THE DAILY MEASUREMENTS AND CONTINUE TO MONITOR THE PATIENT AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED TO REVISE THE LEAD. THE PHYSICIAN ELECTED TO SURGICALLY ABANDON THIS LEAD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED A SLIGHTLY ELEVATED SHOCK IMPEDANCE OF 91 OHMS. THE LATITUDE SYSTEM DISPLAYED A RED STATUS INDICATOR, AND IT WAS QUESTIONED WHY THERE WAS NO RED ALERT GENERATED. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT THIS DEVICE HAS AN UPPER LIMIT OF 125 OHMS AND A RED ALERT WOULD NOT BE TRIGGERED UNTIL THAT MEASUREMENT WAS REACHED. THEY ALSO DISCUSSED THE STATUS INDICATOR IS AN ADDITIONAL FLAG TO ALERT CLINICIANS OF OUT OF RANGE MEASUREMENTS, AND THIS LEAD IS A SINGLE COIL LEAD WHICH WAS LIKELY THE CAUSE OF THE HIGHER IMPEDANCES, WHICH WERE NOTED TO HAVE BEEN IN THE 70 TO 90 OHMS RANGE SINCE IMPLANT. TS RECOMMENDED CONTINUED MONITORING OF THE LEAD. ADDITIONAL INFORMATION WAS PROVIDED THAT THIS ISSUE WAS BEING INVESTIGATED FURTHER DUE TO THE OCCURRENCE OF LATITUDE CREATING A STATUS INDICATOR FOR A SHOCK IMPEDANCE OF 80 OHMS, INSTEAD OF 125 OHMS. THIS WOULD CREATE A STATUS INDICATOR WHEN THERE IS NO ALERT GENERATED FROM LATITUDE. ADDITIONAL INFORMATION WAS LATER PROVIDED THAT A LATITUDE RED ALERT WAS DETECTED DUE TO HIGH SHOCK IMPEDANCES. THE DEVICE WAS BEING CHECKED, AND IT WAS NOTED THAT THE COMMANDED SHOCK LEAD IMPEDANCE TEST (SLIT) RESULTS RANGED FROM 98 TO 100 OHMS. THE PATIENT ALSO REPORTED HEARING BEEP TONES FROM THE DEVICE. TS DISCUSSED THE BEEPING WAS LIKELY DUE TO OUT OF RANGE SHOCK IMPEDANCES, AND RECOMMENDED RESETTING THE CLINICAL EVENT, WHICH WOULD ALSO STOP THE BEEPING. TS DISCUSSED OPTIONS OF TROUBLESHOOTING TO TEST THE INTEGRITY OF THE LEAD AND/OR CONTINUED MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 0181| T180