BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2914301 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00790
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. IT WAS REPORTED THE SHOCK IMPEDANCE MEASUREMENTS TREND BETWEEN 100 AND 110 OHMS. THE PATIENT WAS NOT SEEN IN CLINIC AND WILL CONTINUE TO BE MONITORED THROUGH ROUTINE FOLLOW-UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20613 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 4472| E142| 0292