BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953564 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23988
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    March 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED INDICATED THIS PATIENT PRESENTED TO THE FOLLOW-UP APPOINTMENT AND THERE WAS NO EVIDENCE OF ANY ADDITIONAL OVERSENSING EPISODES. ISOMETRICS WERE PERFORMED WHICH CREATED A SMALL AMOUNT OF NOISE ON THE SHOCK CHANNEL ALONG WITH SMALL BASELINE NOISE ON THE RATE/SENSE, HOWEVER IT WAS NOT BEING MARKED AT NOMINAL SETTINGS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT NOISE ON THE SHOCK CHANNEL IS NOT UNCOMMON DUE TO THE UNIPOLAR VECTOR. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY USED UNGROUNDED STEREO EQUIPMENT BUT HAS STOPPED SINCE THE NOISE EPISODES. IT WAS DISCUSSED THAT LIKELY THE NOISE EPISODES WERE EMI SINCE THERE HAVEN'T BEEN ANY EPISODES SINCE THE PATIENT STOPPED USING THE STEREO EQUIPMENT. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. 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

    ADDITIONAL INFORMATION RECEIVED APPROXIMATELY TWO MONTHS LATE INDICATED THERE WERE ADDITIONAL EPISODES STORED WHICH EXHIBITED MYOPOTENTIAL OVERSENSING. THIS ALSO RESULTED IN GREATER THAN 2 SECONDS OF ASYSTOLE FOR THIS PACEMAKER DEPENDENT PATIENT. THE PATIENT PLANNED TO BE BROUGHT IN FOR ADDITIONAL TROUBLESHOOTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING NOISE ON THE PACE/SENSE AND SHOCK CHANNEL. THE NOISE WAS OVERSENSED WHICH RESULTED IN GREATER THAN 3 SECONDS OF PACING INHIBITION. THE NOISE APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI). THE PATIENT COULD NOT RECALL ANY EVENTS RELATED TO THE TIMEFRAME OF THE EMI. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR MISMATCH| N119| 4470| 0184