BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    MDR report key: 8471651 · Received April 1, 2019

    Report

    Report Number
    3010676138-2019-00019
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 1, 2019
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020495
    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 DEVICE MIGRATION THAT WAS REPORTED TO STIMWAVE ON (B)(6) 2019, BY TERRITORY MANAGER, (B)(6). ON (B)(6) 2019 THE PATIENT ATTENDED AN APPOINTMENT WITH THEIR IMPLANTING CLINICIAN AND TERRITORY MANAGER FOR DEVICE REPROGRAMMING BECAUSE HE WAS NOT EXPERIENCING PAIN RELIEF WITH HIS DEVICE. AN X-RAY TAKEN ON THIS DATE SHOWED THE SUPERIOR CLUNEAL LEAD MIGRATED CAUDAL AND POSTERIOR INTO HIS LEG. THE DEVICE AT THE MEDIAL CLUNEAL NERVE HAD NOT MIGRATED, THUS TERRITORY MANAGER WAS ABLE TO ESTABLISH STIMULATION WITH THE IMPLANT LOCATED IN THE MEDIAL CLUNEAL. THE IMPLANTING CLINICIAN HAS SCHEDULED THE PATIENT FOR REVISION ON (B)(6) 2019. IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY CONTACTED THE SALES REPRESENTATIVE TO DISCUSS THE EVENTS LEADING UP TO AWARENESS OF THE ISSUE. ON (B)(6) 2019 FOLLOWING A SUCCESSFUL TRIAL WITH THE STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM, THE PATIENT HAD ONE (1) STIMQ STIMULATOR (STQ4-RCV-A0) AND ONE (1) STIMQ SPARE LEAD (STQ4-SPR-B0) IMPLANTED ALONG THE LEFT SUPERIOR CLUNEAL NERVE, AND MEDIAL CLUNEAL NERVE TO TREAT THE PATIENT'S LOW BACK PAIN. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE, AND THE PATIENT WAS DISCHARGED THE SAME DAY REPORTING SIGNIFICANT PAIN RELIEF WITH HIS DEVICE. IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY, REVIEWED THE IMPLANTING CLINICIAN'S PROCEDURE WITH THE TERRITORY MANAGER 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. THE TERRITORY MANAGER RECALLED THAT THE IMPLANTING CLINICIAN PERFORMED ONLY ONE OF THE TWO STEPS FOR MIGRATION MITIGATION. 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). THE TERRITORY MANAGER DID NOT OBSERVE THE IMPLANTING CLINICIAN SECURE THE STIMULATOR; RATHER, HE ONLY FIXATED THE RECEIVER. IT IS POSSIBLE THAT CLINICIAN DID NOT CUT DOWN DEEP ENOUGH TO BURY THE RECEIVER AND SPARE LEAD IN ORDER TO MITIGATE MIGRATION. IT IS EQUALLY LIKELY THAT CLINICIAN'S SUTURE KNOT FAILED. THE SOURCE OF THE ISSUE WAS NOT TRACED BACK TO INADEQUATE DOCUMENTATION OF IMPLANT PROCEDURE, 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, SECURING THE STIMULATOR AND ANCHORING THE RECEIVER, THIS KIND OF ADVERSE EVENT IS LESS LIKELY TO OCCUR. ADDITIONALLY, GIVEN THE TIME BETWEEN IMPLANT AND ISSUE ONSET (LESS THAN 4 WEEKS), IT IS POSSIBLE THAT THE PATIENT DID NOT COMPLY WITH POST-OPERATIVE INSTRUCTIONS TO REDUCE ACTIVITY TO ALLOW THE DEVICES TO SCAR IN. 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 DEVICE MIGRATION MITIGATION STEPS AS DETAILED IN THE PRODUCT'S INSTRUCTION FOR USE. THE ROOT CAUSE IS ALSO LIKELY ATTRIBUTED TO SUTURE FAILURE AS A RESULT OF A MECHANICAL STRESS (TORSION AND STRAIN) ON THE DEVICE FOLLOWING THE PATIENT'S NATURAL PHYSICAL MOVEMENTS. THE STIMWAVE 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 MIGRATION IS A KNOWN ADVERSE EVENT, MITIGATED AS FAR AS POSSIBLE, AND DOCUMENTED IN THE STIMWAVE RISK MANAGEMENT FILE. STIMWAVE WAS IN CONSTANT CONTACT WITH THE TERRITORY MANAGER FROM (B)(6) 2019, ONWARD REGARDING THE COMPLAINT AND THE ROOT CAUSE INVESTIGATION. THE SOURCE OF THE ISSUE IS ATTRIBUTED TO THE IMPLANTING CLINICIAN'S NONCOMPLIANCE TO DEVICE INDICATIONS FOR USE DETAILED IN THE PRODUCT'S IFU, AND PHYSICAL STRESS AND STRAIN ON THE SUTURES AS A RESULT OF THE PATIENT'S MOVEMENTS. 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 MAY BE 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 APRIL 1, 2019.

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE PATIENT ATTENDED AN APPOINTMENT WITH THEIR IMPLANTING CLINICIAN AND TERRITORY MANAGER FOR DEVICE REPROGRAMMING BECAUSE HE WAS NOT EXPERIENCING PAIN RELIEF WITH HIS DEVICE. AN X-RAY TAKEN ON THIS DATE SHOWED THE SUPERIOR CLUNEAL LEAD MIGRATED CAUDAL AND POSTERIOR INTO HIS LEG. THE DEVICE AT THE MEDIAL CLUNEAL NERVE HAD NOT MIGRATED, THUS TERRITORY MANAGER WAS ABLE TO ESTABLISH STIMULATION WITH THE IMPLANT LOCATED IN THE MEDIAL CLUNEAL. THE IMPLANTING CLINICIAN HAS SCHEDULED THE PATIENT FOR REVISION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264039 STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. STQ4 RCV-A0, STQ4-SPR-B0 SWO180717, SWO180808 00818225020495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention