BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3955928 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14311
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 22, 2014
    Report Date
    February 5, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    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 EXHIBITED NOISE AND OVERSENSING WHICH RESULTED TO PACING INHIBITION WITH GREATER THAN 2 SECONDS OF ASYSTOLE. ADDITIONALLY, THE PACING THRESHOLD MEASUREMENT HAD SLIGHTLY INCREASED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE SOURCE COULD BE DIAPHRAGMATIC IN NATURE. SUBSEQUENTLY, THE PATIENT WAS EVALUATED IN THE CLINIC AND THE PHYSICIAN HAS ELECTED TO CONTINUE WITH FOLLOW-UP. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REVIEW OF ELECTROGRAMS (EGMS) ON THE REMOTE HOME MONITORING SYSTEM FOUND OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. IT WAS NOTED THAT THE NOISE HAD BEEN ONGOING FOR AT LEAST EIGHT MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND IT WAS FOUND THAT THE RESPIRATORY RATE SENSOR WAS PROGRAMMED ON. ONCE IT WAS PROGRAMMED OFF, NOISE SEEN ON THE VENTRICULAR CHANNEL WAS NO LONGER SEEN. IT WAS DETERMINED THAT THIS WAS THE SOURCE OF THE NOISE. THE SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433156 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4568| E110| 1861