BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 14837211 · Received June 27, 2022

    Report

    Report Number
    3015425075-2022-00033
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    October 5, 2021
    Report Date
    June 27, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537035444
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(4) 2022 THE FIRM WAS MADE AWARE OF A REVISION PROCEDURE PREFORMED ON (B)(6) 2021. INITIAL COMMUNICATION FROM THE PATIENT AND DOCTOR ON (B)(6) 2021 INDICATED THAT THE EXTERNAL THERAPY DISC WAS NOT CONNECTING CONSISTENTLY TO THE IMPLANTED IPG COMPONENT. COMPANY REPRESENTATIVE ATTEMPTED MULTIPLE POSITIONS AND PRESSURES WITHOUT SUCCESS AND RECOMMENDED AN ULTRASOUND TO DETERMINE DEPTH AND POSITION OF THE IMPLANTED IPG. COMPANY FIELD REPRESENTATIVE REPORTED TO IT ON (B)(4) 2022 THAT A REVISION WAS PERFORMED ON (B)(6) 2021. THE UPDATE WAS RELAYED TO COMPANY QUALITY REPRESENTATIVES ON 27MAY2022. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751006 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 34001-001 00812537035444

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other