BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780050 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12792
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. AN UPDATED REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE ICD AND LEAD REMAIN IMPLANTED AND IN SERVICE. ATTEMPTS WERE MADE TO OBTAIN THE LEAD'S SERIAL NUMBER BUT WERE UNSUCCESSFUL. 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 RIGHT VENTRICULAR (RV) LEAD IS PART OF AN IMPLANTED SYSTEM (WITH DEVICE T165/(B)(4)) THAT EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. BOSTON SCIENTIFIC RECOMMENDED REPLACEMENT OF THIS RV DEFIBRILLATION LEAD AND THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. A REVIEW OF THE DATA FOUND THAT THE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN HIGH AND VARIABLE SINCE IMPLANT AND THEN INCREASED TO ABOVE 125 OHMS FOUR MONTHS LATER. A TS CONSULTANT DISCUSSED THAT IT IS POSSIBLE TO HAVE HIGH SHOCK IMPEDANCE MEASUREMENTS WHILE HAVING TRUE HIGH VOLTAGE MEASUREMENTS IN NORMAL RANGE IF THERE IS A "SMALL OPEN CONDITION" WITHIN THE LEAD OR A LOOSE SETSCREW IN THE DEVICE HEADER. THIS OPEN CONDITION MAY BE LARGE ENOUGH TO NOT ALLOW THE LOW VOLTAGE TO PASS FROM THE HEADER TO THE LEAD'S TERMINAL PIN DURING PAINLESS IMPEDANCE MEASUREMENTS BUT SMALL ENOUGH FOR HIGH VOLTAGE TO ARC ACROSS DURING MAXIMUM ENERGY SHOCK DELIVERY. THIS IS INDICATIVE OF A LEAD FRACTURE OR A POOR CONNECTION ISSUE. A REVIEW OF THE LOGBOOK FOUND THAT WHEN SHOCK DELIVERY HAS OCCURRED, THE SHOCK IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE AND THE ENERGY WAS ABLE TO CONVERT THE PATIENT'S ARRHYTHMIA. HOWEVER, THERAPY DELIVERY OVER TIME CANNOT CONTINUE TO BE GUARANTEED AS EITHER THE LEAD OR CONNECTIONS ARE SUSPECTED TO BE COMPROMISED. IT WAS ALSO DISCUSSED THAT THE PATIENT SHOULD BE CLOSELY MONITORED UNTIL THE ICD IS TO BE REPLACED AND DURING THE PROCEDURE, TESTING SHOULD BE PERFORMED ON THE LEAD TO ENSURE ITS INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 4087| 0185| T165