BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875099 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18909
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ECHOCARDIOGRAM WAS PERFORMED ON THIS PATIENT, WHICH INDICATED THAT THIS PATIENT HAD NOT EXPERIENCED A CARDIAC EFFUSION AND NO OTHER ADVERSE PATIENT EFFECTS HAVE BEEN OBSERVED. AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT DFT TESTING WAS PERFORMED TO VERIFY LEAD INTEGRITY. DURING THE TESTING, ONE 21J SHOCK CONVERTED THE PATIENT'S INDUCED ARRHYTHMIA. ALL SENSING AND IMPEDANCE MEASUREMENTS ARE WITHIN NORMAL LIMITS, HOWEVER, NO CAPTURE CAN BE ACHIEVED DISPITE MAXIMUM PACING OUTPUTS. THE PATIENT'S PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR THIS LEAD. 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 CRM RECEIVED INFORMATION THAT APPROXIMATELY TWO WEEKS POST IMPLANT, COMPLETE LOSS OF CAPTURE WAS OBSERVED ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD DESPITED PACING OUTPUTS OF 7.5 V AT 2.0 MS. ADDITIONALLY, IT WAS NOTED THAT PACING IMPEDANCE MEASUREMENTS HAD DECREASED FROM 1100 TO 500 OHMS. IT WAS REPORTED THAT JUST AFTER THE IMPLANT PROCEDURE, A SLIGHT INCREASE IN PACING THRESHOLDS WAS OBSERVED, SO A CHEST X-RAY WAS PERFORMED WHICH CONFIRMED THAT THE LEAD HAD MOVED SLIGHTLY SINCE THE IMPLANT. HOWEVER, AT THAT TIME, THE PHYSICIAN PLANNED TO CONTINUE TO MONITOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR E102| 0185