BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910292 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17288
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED SHOCK IMPEDANCE MEASUREMENTS ABOVE 125 OHMS. A COMMANDED SHOCK AT 0.6 JOULES WAS PERFORMED AND THE SHOCK IMPEDANCE VALUE WAS IN NORMAL RANGE. THE DEVICE WAS TESTED AGAIN THE FOLLOWING DAY WITH A COMMANDED SHOCK OF 1.1 JOULES AND A YELLOW WARNING MESSAGE STATED TO CHECK THE LEAD SYSTEM WAS DISPLAYED. IN ADDITION, THE PACING THRESHOLD MEASUREMENTS HAD INCREASED. THE ICD HAD ONLY BEEN IMPLANTED FOR A FEW DAYS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR FURTHER ASSISTANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A TS CONSULTANT CONFIRMED THAT THE DAILY MEASUREMENTS HAVE SHOWN >125 OHMS SINCE IMPLANT AND ADVISED THAT A 1.1 J SHOCK SHOULD BE PERFORMED TO TEST THE INTEGRITY OF THE SYSTEM. TESTING WAS REPEATED AT 1.1 J AND WAS DETECTED. THE TS CONSULTANT DISCUSSED THAT THE YELLOW WARNING MESSAGE IS INDICATES AN OPEN CIRCUIT CONDITION THAT IS MOST LIKELY THE RESULT OF A CONNECTION ISSUE. IT WAS ALSO DISCUSSED THAT A REVISION SHOULD BE CONSIDERED TO VERIFY THE CONNECTIONS BETWEEN THE DEVICE AND THE RV LEAD. IN ADDITION, AN INCREASE IN PACING THRESHOLD MEASUREMENTS WERE ALSO CONFIRMED; HOWEVER, ALL THE PACING IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE. THE TS CONSULTANT DISCUSSED WHAT MAY BE CAUSING THE INCREASE IN THRESHOLDS AND THE LEAD CAN BE EVALUATED AT THE SAME TIME THE CONNECTIONS ARE BEING VERIFIED. ADDITIONAL INFORMATION WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED AND IT WAS CONFIRMED THERE WAS A LOOSE CONNECTION. THE RV LEAD WAS SECURED IN THE HEADER AND ALL SHOCK IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE. THE ICD AND RV LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16904 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R