BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950496 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22531
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REVIEW AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) WITH RETROGRADE CONDUCTION. THE DEVICE WAS TEMPORARILY REPROGRAMMED TO VVI AND THE MEASURED RETROGRADE CONDUCTION WAS 180 MS. THE LOCAL REPRESENTATIVE COMPARED THE CURRENT PROGRAMMED PARAMETERS (DETECTION ENHANCEMENT FEATURES) WITH THE MEASURED VALUES. THE PHYSICIAN WANTED THE DEVICE TO DELIVER SOONER, HOWEVER, THE ATRIAL FIBRILLATION RATE THRESHOLD (AFRT) FEATURE WAS IMPACTED BECAUSE OF THE PATIENT'S RETROGRADE CONDUCTION. ADDITIONALLY, TECHNICAL SERVICES WAS INFORMED THAT THE DEVICE'S FIRST PROGRAMMED THERAPY ZONE (VT-1 ZONE) HAD BEEN PROGRAMMED TO MONITOR ONLY. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS TO MITIGATE THE RETROGRADE ISSUE SINCE RETROGRADE WAS AFFECTING THE DEVICE'S DETECTION ENHANCEMENT DECISIONS. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO AGAIN DISCUSS OPTIONS FOR PROGRAMMING DETECTION ENHANCEMENTS. ADDITIONALLY, THE LOCAL REPRESENTATIVE INFORMED TECHNICAL SERVICES THAT THE PHYSICIAN WAS REQUESTING CHANGES TO THE PROGRAMMABLE VT-1 ZONE. THE PHYSICIAN WANTED THE DEVICE'S VT-1 ZONE TO TREAT SPONTANEOUS ARRHYTHMIAS WITH ANTITACHYCARDIA PACING (ATP) EXCLUDING SPONTANEOUS ATRIAL TRACHYCARDIA (AT) WHICH DEVELOPS AT A RATE OF 150 BPM. TECHNICAL SERVICES DISCUSSED THE MATRIX OF DETECTION ENHANCEMENTS AND EXPLAINED THAT REPROGRAMMING MAY NOT ADDRESS ALL OF THE PHYSICIAN'S REQUESTS. THE LOCAL REPRESENTATIVE WAS PLANNING TO DISCUSS THIS FURTHER WITH THE PHYSICIAN. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN OUT-OF-SERVICE (OOS) FORM THAT THIS PATIENT'S DEVICE AND ENTIRE LEAD SYSTEM WERE EXPLANTED. A "VEGETATION" WAS IDENTIFIED ON THE RIGHT VENTRICULAR (RV) LEAD WHICH NECESSITATED THE EXPLANT OF THE ENTIRE IMPLANTED SYSTEM.

    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 62 YR Hospitalization| L| R 0184| 4469| N119| 4542