BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212498 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09318
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 26, 2013
    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 PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCK IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS IN A BLOOD DRAW LAB AROUND LARGE EQUIPMENT DURING THE TIME OF THE OUT OF RANGE MEASUREMENT, SO IT WAS LIKELY THE RESULT OF ELECTROMAGNETIC INTERFERENCE (EMI) WHICH THE PHYSICIAN AGREED WITH. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO CHANGES TO THE SYSTEM HAVE BEEN MADE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AND THE RV LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312150 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 1861| T125| 0148| 4087| E110