BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040777 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02222
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    November 15, 2012
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AND DEFIBRILLATION WAS SUCCESSFUL AT THE PROGRAMMED PARAMETERS. THE SYSTEM REMAINS IN SERVICE AND NO FURTHER REPROGRAMMING WAS DONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE WITH OVERSENSING, WHICH RESULTED IN PACING INHIBITION LASTING GREATER THAN TWO SECONDS. THESE OBSERVATIONS HAVE BEEN OBSERVED ON A FEW OCCASIONS SINCE THE PATIENTS AV NODE ABLATION THIS (B)(6). THE PATIENT WAS EVALUATED IN CLINIC AND TROUBLESHOOTING WAS DONE, BUT NO NOISE WAS REPRODUCED, AND THRESHOLDS AND IMPEDANCES WERE UNCHANGED. A RECENT ALERT FOR A LOW R-WAVE AMPLITUDE CAME THOUGH, BUT IT IS SUSPECTED THAT WAS NOISE AS THE PATIENT IS PACEMAKER DEPENDENT AFTER HAVING AN AV NODE ABLATION. A STRIP WAS FAXED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW AND IT WAS DISCUSSED THAT THE NOISE APPEARED TO BE CONSISTENT WITH MYOPOTENTIAL OR DIAPHRAGMATIC OVERSENSING. THE PLAN WAS FOR THE PATIENT TO RETURN TO THE CLINIC FOR FURTHER EVALUATION AND TROUBLESHOOTING TO INCLUDE DEEP BREATHING, COUGHING AND VALSALVA MANEUVER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EVALUATED IN THE CLINIC AND DIAPHRAGMATIC MANEUVERS WERE PERFORMED. THE NOISE WAS REPRODUCIBLE WITH YAWNING, AND OVERSENSING WAS NOTED RESULTING IN ONE MISSED BEAT. THE TESTING WAS PRINTED IN REAL-TIME AND DETERMINED TO BE CONSISTENT WITH WHAT WAS SEEN ON THE STORED EVENTS. ALL MEASUREMENTS ON THE LEAD WERE WITHIN NORMAL RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS NOTED BY THE PATIENT. THE PHYSICIAN REPROGRAMMED THE RV SENSITIVITY TO 1.0MV AND FOLLOW-UP A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PLANNED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143102 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening 0184| E102