BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3936010 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13795
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    March 26, 2014
    Report Date
    February 5, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RECEIVED THAT THIS PATIENT WILL BE FOLLOWED VIA THE REMOTE HOME MONITORING SYSTEM. IT WAS DETERMINED THAT THE IMPEDANCES HAVE STABILIZED AROUND 2,200 OHMS. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE IMPEDANCE MEASUREMENTS NOW EXCEED 2,500 OHMS. SENSING APPEARS TO BE GOOD AND STABLE AND THERE ARE NO NEW EPISODES IN THE LOGBOOK. IT IS LIKELY THAT THERE IS A LEAD TIP/TISSUE INTERFACE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED AN GRADUAL INCREASE IN PACE IMPEDANCE MEASUREMENTS, WHICH ARE NOW GREATER THAN 2,000 OHMS. ADDITIONALLY, THERE WAS AN INCREASED IN PACING THRESHOLDS. ISOMETRICS WERE PERFORMED AND THERE WAS NO NOISE SEEN ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD CHANNELS. THE SHOCK IMPEDANCE MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414125 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1 F140| 0285