BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

    MDR report key: 18994296 · Received March 27, 2024

    Report

    Report Number
    MW5153327
    Event Type
    Other
    Date Received
    March 27, 2024
    Report Date
    March 27, 2024
    Manufacturer
    CURONIX LLC
    Product Code
    GZF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ON 07 FEBRUARY 2024 THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INEFFECTIVE THERAPY. DURING THE PROCEDURE, A CURONIX ELECTRODE WAS ALSO EXPLANTED. IN ADDITION, PUS WAS NOTED DURING THE EXPLANT PROCEDURE. THE EXPLANT OCCURRED ON (B)(6) 2024. 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
    2048026 STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF CURONIX LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown