BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873802 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17687
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    May 15, 2010
    Report Date
    January 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT AN ADDITIONAL EPISODE OF NOISE WAS DETECTED ON THE RV LEAD. THE NOISE WAS OVERSENSED RESULTING IN PACING INHIBITION FOR FOUR SECONDS. ADDITIONALLY, PACING IMPEDANCE MEASUREMENTS HAD CHANGED BY 500 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED FOUR DAYS LATER. THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LEFT SIDED OCCLUSION. A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RETURN OF THIS PRODUCT IS NOT EXPECTED AT THIS TIME. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION SUGGESTS THAT THE PHYSICIAN WILL LIKELY MONITOR THE SITUATION AT THIS TIME. CURRENT RECORDS SUGGEST THAT THESE PRODUCTS REMAIN IMPLANTED AND IN SERVICE. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A SINGLE EPISODE OF NOISE ON THE RV RATE/SENSE CHANNEL, RESULTING IN APPROXIMATELY 9 SECONDS OF PACING INHIBITION. THE PATIENT IS PACEMAKER DEPENDENT, BUT DID NOT REPORT FEELING SYMPTOMATIC AT THE TIME. ALL DIAGNOSTIC LEAD MEASUREMENTS ARE STABLE AND WITHIN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 4470| 4064| 1861| 0148| T165