BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905643 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11540
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED A SINGLE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION, NO FURTHER DETAILS REGARDING THE FOLLOW-UP ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384538 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 F142| 0293