BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041283 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01252
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 6, 2013
    Report Date
    March 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED

    Additional Manufacturer Narrative · 1

    AS THIS LEAD WAS SURGICALLY ABANDONED, NO FURTHER INFORMATION IS EXPECTED REGARDING THIS EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF A DEVICE WITH UNKNOWN RIGHT VENTRICULAR LEAD DETECTED A HIGH OUT OF RANGE (OOR) SHOCK IMPEDANCE MEASUREMENT. THE PHYSICIAN NOTED THAT HE SAW THE PATIENT FOR A FOLLOW-UP RECENTLY, AND A RED ALERT WAS NOT OBSERVED FOR THE HIGH OUT OF RANGE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONTACTED TO DISCUSS THE REASONING BEHIND THIS. TS DISCUSSED THAT THE PROGRAMMER WILL NOT DISPLAY A RED ALERT, BUT WILL PROMPT TO CHECK THE SHOCK LEAD. IF THE LEAD MEASUREMENTS WERE CHECKED, THEN AN OOR SHOCK IMPEDANCE MEASUREMENT WOULD BE OBSERVED. IT WAS NOTED THE SHOCK IMPEDANCE HAS BEEN FLUCTUATING SINCE IMPLANT. A REVIEW OF THE MOST CURRENT EPISODES SHOWS APPROPRIATE SENSING AND NO NOISE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN FOLLOWED-UP WITH PATIENT, AND WAS NOT CONCERNED ABOUT LEAD INTEGRITY. THERE WERE NO SHOCKS DELIVERED, AND THE DEVICE APPEARED TO BE OPERATING NORMALLY. NO REVISION PROCEDURE WAS INTENDED. APPROXIMATELY ONE YEAR LATER, A REVIEW OF THE REMOTE MONITORING DATA REVEALED SIX OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN ADDITION, THIS RIGHT VENTRICULAR LEAD IS IMPLANTED. AVAILABLE INFORMATION INDICATED THAT THIS ISSUE HAS BEEN MONITORED BY THE PHYSICIAN EVERY TWO MONTHS AND A DECISION REGARDING A LEAD REVISION PROCEDURE IS INTENDED AFTER FURTHER SYSTEM INTEGRITY VERIFICATION. AS OF THIS DATE, THIS RIGHT VENTRICULAR LEAD AND DEVICE REMAIN IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. FURTHER FLUCTUATING SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. TECHNICAL SERVICES WAS CONTACTED AND RECOMMENDED FURTHER SYSTEM INTEGRITY TROUBLESHOOTING TO ASSURE THAT THERAPY IS NOT COMPROMISED. TS RECOMMENDED COMMANDED SHOCKS OF 1.1J AND 41J IN THE PROGRAMMED TRIAD VECTOR TO ASSESS THE ACTUAL IMPEDANCE OF A DELIVERED SHOCK. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A LEAD REVISION WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NORMAL SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ENGINEERING REVIEWED THE DATA. THERE WAS CONCERN THAT THERE MAY BE A RV COIL ISSUE. FURTHER LEAD INTEGRITY VERIFICATION HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143657 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization 4087| 1861| E110| 0165