BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12025991 · Received June 18, 2021

    Report

    Report Number
    3010676138-2021-00128
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020464
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS INSTRUCTED TO KEEP THE DEVICE OFF UNTIL THE DEVICE IS REMOVED. THE PATIENT DISCLOSED HAVING ISSUES WITH A SCREW PLACED IN HIS HIP (NOT RELATED TO THE STIMWAVE DEVICE) AND HAVING A BLISTER WHERE THE ANTENNA WAS PLACED. THE NO THERAPY/LOSS OF THERAPY QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPROPER PLACEMENT OF THE DEVICE, IMPLANTING A DAMAGED DEVICE, PATIENT ENGAGING IN EXCESSING TWISTING, STRETCHING, OR STRENUOUS ACTIVITIES, AND PATIENT HAVING CO-MORBIDITIES HAVE BEEN RULED OUT AS POTENTIAL CAUSES. HOWEVER, THE CLINICAL REPRESENTATIVE STATED THE SKIN IRRITATION HAS OCCURRED DUE TO A BLISTER WHERE THE ANTENNA WAS WORN. THE PATIENT WAS NOT COMPLIANT WITH IFU BY WEARING THE ANTENNA DIRECTLY ON THE SKIN. THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN, BUT IS LIKELY RESULTANT OF THE NON-STIMWAVE HARDWARE IMPLANTED OR PRIOR HIP INJURY. THE CAUSE OF THE SKIN IRRITATION IS DUE TO IMPROPER ANTENNA PLACEMENT DUE TO PATIENT USER ERROR BY WAY OF NON-COMPLIANCE TO THE IFU.

    Description of Event or Problem · 1

    THE PATIENT IS COMPLAINING OF PAIN. THE IMPLANTING CLINICIAN SAW THE PATIENT AND AN EXPLANT PROCEDURE WAS SCHEDULED FOR (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923512 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0 SWO201025 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention