BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPICARDIAL LEAD

    MDR report key: 10219807 · Received July 1, 2020

    Report

    Report Number
    6000030-2020-00180
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    April 1, 2020
    Report Date
    July 1, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    UDI-DI
    00681490116503
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTBA1D4 CRTD; 6935M55 LEAD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE RIGHT ATRIAL (RA) LEAD. X-RAY SHOWS THE LEAD WAS DISLODGED AND THE TIP IN A DIFFERENT POSITION. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RA EPICARDIAL LEAD CAUSED PHRENIC NERVE STIMULATION. THE RA EPICARDIAL LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682098 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 22 YR Hospitalization| R