BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEVRO LEADS

    MDR report key: 18994377 · Received March 27, 2024

    Report

    Report Number
    MW5153329
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Report Date
    February 26, 2024
    Manufacturer
    NEVRO CORPORATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ON FEBRUARY 23, 2024 THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THEIR NEVRO LEADS WERE EXPLANTED DUE TO SIGNIFICANT LEAD MIGRATION. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928362 NEVRO LEADS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEVRO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown