BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 8682300 · Received June 10, 2019

    Report

    Report Number
    6000030-2019-00048
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 10, 2019
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    UDI-DI
    00681490116503
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ADDRL1 IPG, IMPLANTED: (B)(6) 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED FAR FIELD R-WAVE OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475771 CAPSURE EPICARDIAL LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-35 00681490116503

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR 4965-35 LEAD