BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    MDR report key: 8187629 · Received December 20, 2018

    Report

    Report Number
    3010676138-2018-00024
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 20, 2018
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM A MIGRATION REPORTED TO STIMWAVE ON (B)(6) 2018, BY STIMWAVE TERRITORY MANAGER. FOLLOWING A SUCCESSFUL TRIAL STIMULATOR IMPLANT WITH NO COMPLICATIONS AND ADEQUATE PAIN RELIEF, THE PATIENT HAD A PERMANENT PROCEDURE PERFORMED ON (B)(6) 2018. A STIMQ STIMULATOR (STQ4-RCV-A0) AND STIMQ SPARE LEAD (STQ4-SPR-B0) WERE IMPLANTED IN THE ILIOINGUINAL REGION FOR ILIOINGUINAL PAIN. NO COMPLICATIONS OCCURRED DURING THE PROCEDURE, AND THE PATIENT RECEIVED 100% PAIN RELIEF. ON (B)(6) 2018, THE PATIENT COMPLAINED TO THE IMPLANTING CLINICIAN OF SKIN IRRITATION AND A SUSPECTED MIGRATED STIMULATOR. AT A FOLLOW-UP APPOINTMENT WITH THE IMPLANTING CLINICIAN ON AN UNKNOWN DATE, THE CLINICIAN CONFIRMED THE MIGRATION (METHOD UNKNOWN). THE PATIENT OPTED NOT TO EXPLANT THE MIGRATED STIMULATOR AT THIS TIME, AS SHE WAS STILL RECEIVING PAIN RELIEF. A PROCEDURE TO REVISE THE MIGRATED STIMULATOR WILL BE SCHEDULED (EXACT DATE UNKNOWN). IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY, STIMWAVE MANAGEMENT, AND THE TERRITORY MANAGER REVIEWED THE IMPLANTING CLINICIAN'S PROCEDURE COMPARED TO THE RECEIVER INSTRUCTIONS FOR USE. THE TERRITORY MANAGER STATED THAT THE IMPLANTING CLINICIAN DID NOT COMPLY WITH THE PRODUCT INSTRUCTIONS FOR USE WITH RESPECT TO SECURING THE STIMULATOR AND ANCHORING THE RECEIVER. PER THE TERRITORY MANAGER, THE IMPLANTING CLINICIAN DID NOT SECURE OR ANCHOR THE STIMULATOR AND SPARE LEAD WITH A SUTURE. ADDITIONALLY, AGAINST POST-OPERATIVE CARE INSTRUCTIONS, THE PATIENT STATED THAT SHE ENGAGED IN SIGNIFICANT PHYSICAL ACTIVITY IMMEDIATELY AFTER THE IMPLANT PROCEDURE. THE PROCEDURE FOR SECURING THE STIMULATOR INSTRUCTS CLINICIANS TO ENSURE THE STIMULATOR IS SUTURED TO THE TISSUE (05-0669-2, PAGE 24, K171366), AND FOR FIXATING THE RECEIVER, PHYSICIANS MAY NEED TO CUT DOWN IN ORDER TO FIND A SUITABLE TISSUE STRUCTURE FOR ANCHORING (05-0669-2, PAGE 26, K171366). IT IS POSSIBLE THAT CLINICIAN DID NOT CUT DOWN DEEP ENOUGH TO BURY THE RECEIVER AND SPARE LEAD IN ORDER TO MITIGATE MIGRATION. ADDITIONALLY, THE CLINICIAN DID NOT INDEPENDENTLY SECURE AND FIXATE THE DEVICES TO TISSUE. THE IFU STATES THAT EACH DEVICE SHOULD BE SECURED AND FIXATED BEFORE ADVANCING TO THE NEXT PART OF THE PROCEDURE. POST-OPERATIVE CARE INSTRUCTIONS STATE TO REFRAIN FROM ENGAGING IN PHYSICAL ACTIVITY UNTIL THE IMPLANT SITE HAS HAD TIME TO HEAL, SECURING THE STIMULATOR(S). THE SOURCE OF THE ISSUE WAS NOT TRACED BACK TO INADEQUATE DOCUMENTATION OF THE IMPLANT PROCEDURE OR POST-OPERATIVE CARE INSTRUCTIONS, AND THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. STIMULATOR MIGRATION IS A KNOWN ADVERSE EVENT FOR PERIPHERAL NERVE STIMULATORS AND THE STIMQ PNS SYSTEM AND IS MITIGATED AS FAR AS POSSIBLE IN THE PRODUCT'S RISK MANAGEMENT FILE. STIMWAVE BELIEVES THAT IF THE IMPLANTING CLINICIAN WOULD HAVE FOLLOWED THE IFU BY SECURING THE STIMULATOR AND ANCHORING THE RECEIVER, AND THAT IF THE PATIENT HAD COMPLIED WITH POST-OPERATIVE INSTRUCTIONS TO LIMIT PHYSICAL ACTIVITY, THIS TYPE OF ADVERSE EVENT WOULD BE LESS LIKELY TO OCCUR. THE IMPLANTING CLINICIAN STATED THAT HE WOULD BE SURE TO FOLLOW THE INSTRUCTIONS FOR USE FOR SECURING THE STIMULATOR AND FIXATING THE RECEIVER. THE PATIENT STATED THAT SHE WOULD COMPLY WITH POST-OPERATIVE INSTRUCTIONS TO LIMIT ACTIVITY TO SURE THE DEVICE DOES NOT MIGRATE IN THE FUTURE. THE ROOT CAUSE OF THE COMPLAINT IS NOT ATTRIBUTED TO DEVICE FAILURE, THE INABILITY OF THE DEVICE TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS, NOR NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO THE IMPLANTING CLINICIAN'S NONCOMPLIANCE TO MIGRATION MITIGATION STEPS DETAILED IN THE PRODUCT'S IFU, AND THE PATIENT'S NONCOMPLIANCE TO POST-OPERATIVE CARE INSTRUCTIONS BY ENGAGING IN HIGH LEVELS OF PHYSICAL ACTIVITY FOLLOWING THE PROCEDURE. THE STIMQ PRODUCT WAS NOT THE SOURCE OF THE ISSUE. CORRECTIVE ACTION IS NOT REQUIRED TO REMEDY THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. STIMWAVE HAS CONFIRMED THAT THE ISSUE IS A KNOWN ADVERSE EVENT, MITIGATED AS FAR AS POSSIBLE, AND DOCUMENTED IN THE STIMWAVE'S RISK MANAGEMENT FILE. STIMWAVE WAS IN CONSTANT CONTACT WITH THE TERRITORY MANAGER FROM (B)(6) 2018 AND ONWARD REGARDING THE COMPLAINT AND THE ROOT CAUSE INVESTIGATION. STIMWAVE CONFIRMED THAT THE IMPLANT PROCEDURE DETAILS STEPS TO MITIGATE MIGRATION, AND THE PRODUCT DID NOT FAIL TO MEET PERFORMANCE AND SAFETY SPECIFICATIONS. THE SOURCE OF THE ISSUE IS ATTRIBUTED TO THE IMPLANTING CLINICIAN'S NONCOMPLIANCE TO MIGRATION MITIGATION STEPS DETAILED IN THE PRODUCT'S IFU AND PATIENT NONCOMPLIANCE TO POST-OPERATIVE CARE INSTRUCTIONS. STIMWAVE HAS INFORMED ALL PARTIES THAT THE PRODUCT WAS NOT THE SOURCE OF THE ISSUE. IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETERMINED THAT THIS ISSUE IS CONSIDERED REPORTABLE AS MIGRATION CAN LEAD TO AN INJURY, AND MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. STIMWAVE HAS REPORTED THIS AS AN ADVERSE EVENT TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) ON (B)(6) 2018.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT COMPLAINED TO THE IMPLANTING CLINICIAN OF SKIN IRRITATION AND A SUSPECTED MIGRATED STIMULATOR. AT A FOLLOW-UP APPOINTMENT WITH THE IMPLANTING CLINICIAN ON AN UNKNOWN DATE, THE CLINICIAN CONFIRMED THE MIGRATION (METHOD UNKNOWN). THE PATIENT OPTED NOT TO EXPLANT THE MIGRATED STIMULATOR AT THIS TIME, AS SHE WAS STILL RECEIVING PAIN RELIEF. A PROCEDURE TO REVISE THE MIGRATED STIMULATOR WILL BE SCHEDULED (EXACT DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026600 STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4-RCV-A0;STQ4-SPR-B0 SWO180720;SWO18071 00818225020464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention