BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043370 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02081
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LEAD IS A SINGLE COIL LEAD AND CAN EXHIBIT HIGHER SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE AND LEAD. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE AND 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 RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146458 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR N140| 4135| 0292| 4555