BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11024223 · Received December 16, 2020

    Report

    Report Number
    3010676138-2020-00172
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 16, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED ATTENDING A FOLLOW-UP APPOINTMENT WITH A PRIMARY CARE PHYSICIAN, WHO ADVISED THE PATIENT TO FOLLOW-UP WITH THE IMPLANTING CLINICIAN BECAUSE THE WOUND SEEMED TO BE INFECTED AND ONE OF THE LEADS APPEARED TO BE ERODING. THE PATIENT REACHED OUT TO THE CLINICAL REPRESENTATIVE IMMEDIATELY. THE CLINICAL REPRESENTATIVE RECOMMENDED THE PATIENT CALL THE IMPLANTING CLINICIAN'S OFFICE AND SCHEDULE A FOLLOW-UP. ON (B)(6) 2020, THE PATIENT WAS SEEN BY ONE OF THE ASSOCIATES OF THE IMPLANTING CLINICIAN, WHO DETERMINED THAT THE TAIL OF THE LEAD WAS PROTRUDING OUT OF THE PATIENT'S INCISION AND RECOMMENDED THE LEADS BE REMOVED AND RE-IMPLANTED. THE PATIENT WAS INSTRUCTED TO FOLLOW-UP WITH THE IMPLANTING CLINICIAN ON (B)(6) 2020, TO DISCUSS FURTHER OPTIONS. THE PHYSICIAN DID NOT PRESCRIBE ORAL ANTIBIOTICS. ON (B)(6) 2020, THE IMPLANTING CLINICIAN CANCELED THE FOLLOW-UP APPOINTMENT WITH THE PATIENT. THE IMPLANTING CLINICIAN TOLD THE PATIENT THAT THE PLAN IS TO EXPLANT AND IMPLANT NEW LEADS IMMEDIATELY AFTER BWC GRANTS THE APPROVAL. THE PROCEDURE WAS REPORTED TO HAVE BEEN PERFORMED PER THE PRODUCT IFU. STIMWAVE HAS CONFIRMED THAT THE PRODUCT WAS DELIVERED STERILE, VALIDATED STERILIZATION PARAMETERS WERE USED, AND STERILE BARRIERS WERE VERIFIED TO BE INTACT FOLLOWING PACKAGING. BASED ON THIS INFORMATION, THE EROSION WAS CONFIRMED/REPLICATED, AND THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE INFECTION AND EROSION COULD NOT BE CONCLUDED WITH THE AVAILABLE INFORMATION (NO PROBLEM FOUND).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CLINICAL REPRESENTATIVE WAS MADE AWARE THAT A RECENTLY IMPLANTED PATIENT WAS SUSPECT OF POTENTIAL INFECTION AND EROSION AT THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486508 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0, STQ4-SPR-B0 SWO200305, SWO200320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention