BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852724 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14520
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL WHICH WAS OVERSENSED AND RESULTED IN NON-SUSTAINED EPISODES. PACING WAS INHIBITED FOR JUST OVER TWO SECONDS. ALL MEASUREMENTS WERE WITHIN RAGE. TECHNICAL SERVICES (TS) DISCUSSED BRINGING THE PATIENT INTO THE OFFICE FOR FURTHER EVALUATION AND TRYING TO REPRODUCE THE NOISE. TS DISCUSSED THAT THE NOISE MORPHOLOGY RESEMBLED THAT OF A LEAD FRACTURE RATHER THAN ELECTROMAGNETIC INTERFERENCE OR MUSCLE STIMULATION. TS ALSO DISCUSSED THE POSSIBILITY OF SEAL PLUG DAMAGE BUT THIS WAS LESS LIKELY. THE AUTOMATIC GAIN CONTROL WAS ADJUSTED PER THE PHYSICIAN'S RECOMMENDATION AND THE PATIENT WILL BE MONITORED. NO ADVERSE PATIENT EFFECTS HAVE BEEN 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 71 YR 4555| 4086| N119| 0184