BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771381 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12483
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, WHICH WAS OVERSENSED AND INHIBITED RV PACING. IT WAS ALSO NOTED THAT THERE WAS LOSS OF CAPTURE DURING BI-VENTRICULAR TRIGGER PACING, WHICH WAS TRIGGERING OFF OF NOISE. IT WAS NOTED THAT ALL OTHER LEAD MEASUREMENTS WERE STABLE. TECHNICAL SERVICES (TS) DISCUSSED SEVERAL POSSIBLE CAUSES FOR THE NOISE AND RECOMMENDED EVALUATING THE LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A LEAD REVISION WAS PERFORMED, DURING WHICH IT WAS DISCOVERED THAT THE PATIENT'S SUBCLAVIAN VEIN HAD OCCLUDED. THE LEAD WAS EXPLANTED AND REPLACED, AND THE PATIENT RECEIVED A NEW DEVICE IMPLANTED SUBPECTORALLY AS WELL. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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 78 YR Required Intervention 4135| 0184| 4548| 4542| N119