BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921674 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12257
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ANOTHER RED ALERT WAS DETECTED FOR HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT. THIS HAS BEEN AN ONGOING ISSUE AND THE SAME RESOLUTION WAS MADE WHEREIN PROGRAMMING WAS PERFORMED AND EVERYTHING WORKED WELL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED AN X-RAY BE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CLINICIAN PROGRAMMED SUPERIOR VENA CAVA COIL OFF AND THE LEAD THEN SEEMED FINE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399915 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 0292| E142| 4076