BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 12019136 · Received June 17, 2021

    Report

    Report Number
    3010676138-2021-00126
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 17, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTING CLINICIAN STATED NO INFECTION WAS PRESENT AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPLANTING A NON-STERILE DEVICE, NOT IRRIGATING THE INCISION SITE, NOT USING ANTIBIOTICS, NOT PREPPING THE SKIN, THE PATIENT INTERFERING WITH THE WOUND, AND USING INAPPROPRIATE TOOLS HAVE BEEN RULED OUT AS POTENTIAL CAUSES. THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE DISCOMFORT IS DUE TO THE GRANULOMA. HOWEVER, THE CAUSE OF THE GRANULOMA IS UNKNOWN/NO PROBLEM FOUND. PER PREVIOUS INVESTIGATIONS CONDUCTED FOR THE SAME REPORTED ISSUE, THE FOLLOWING ARE POTENTIAL CAUSES OF THE EVENT: PLACEMENT OF STIMULATOR TOO NEAR TO THE NERVE. NOT FOLLOWING IFU DURING IMPLANT OF STIMULATOR. STIMULATOR MIGRATION.

    Description of Event or Problem · 1

    THE IMPLANTING CLINICIAN STATED THE PAIN IS RELATED TO A GRANULOMA AT THE INCISION SITE. A REVISION WAS CONDUCTED ON (B)(6) 2021, A SMALL PIECE OF SUTURE WAS REMOVED FROM THE RECEIVER POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911139 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-SPR-B0 SWO191202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention