N
Patient 1
IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY AND THE TERRITORY MANAGER REVIEWED EVENTS PRECEDING THE ISSUE. FOLLOWING A SUCCESSFUL TRIAL, THE PATIENT HAD A PERMANENT PROCEDURE PERFORMED ON (B)(6) 2019, IN WHICH ONE (1) STIMQ SPARE LEAD (STQ4-SPR-B0) WAS IMPLANTED AT THE LATERAL FEMORAL CUTANEOUS NERVE ON THE PATIENT'S LEFT LEG. THE TERRITORY MANAGER WAS NOT PRESENT AT THE TIME OF THE IMPLANT PROCEDURE AND WAS NOT ABLE TO CONFIRM APPROPRIATE SUTURING AND ANCHORING STEPS WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS FOR USE. ON (B)(6) 2019, THE PATIENT CONTACTED THE TERRITORY MANAGER TO REPORT PAIN IN THEIR LEG. THE PATIENT WAS INSTRUCTED TO CONTACT THE IMPLANTING CLINICIAN. THE PATIENT VISITED THE IMPLANTING CLINICIAN THE SAME DAY AND REPORTED THE INCREASED PAIN IN THEIR LEG. THE IMPLANTING CLINICIAN TOOK IMAGING TESTS OF THE PATIENT'S IMPLANT AND THE X-RAYS SHOWED THE DEVICE HAD MIGRATED MEDIALLY TOWARDS THE INSIDE OF THE PATIENT'S LEG. THE IMPLANTING CLINICIAN MADE A NEW INCISION TO REMOVE THE DEVICE. THE EXPLANT PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT REPORTED TO BE GETTING EXTENSIVE PAIN RELIEF PRIOR TO THE TIME OF THE EVENT. SINCE THE PATIENT HAS EXPRESSED INTEREST IN CONTINUING TO USE THE DEVICE, THE IMPLANTING CLINICIAN IS MONITORING THE PATIENT'S HEALING AND WILL SCHEDULE AN IMPLANT PROCEDURE WHEN THE PATIENT IS FULLY HEALED. STIMULATOR MIGRATION IS A KNOWN ADVERSE EVENT FOR PERIPHERAL NERVE STIMULATORS THAT IS MITIGATED AS FAR AS POSSIBLE IN THE PRODUCT'S RISK MANAGEMENT FILE. THE TERRITORY MANAGER WAS NOT PRESENT AT THE TIME OF THE IMPLANT, SO IT IS UNKNOWN AT THIS TIME IF THE ROOT CAUSE IS ATTRIBUTED TO POOR ANCHORING AND SUTURING TECHNIQUE, OR NON-COMPLIANCE TO IMPLANTING INSTRUCTIONS. THE DEVICE DID NOT FAIL TO PERFORM ITS ESSENTIAL FUNCTIONS. UP UNTIL THE MOMENT OF THE REPORTED EVENT, THE PATIENT WAS RECEIVING THERAPY FROM THEIR DEVICE. THE ROOT CAUSE OF THE COMPLAINT IS NOT ATTRIBUTED TO DEVICE FAILURE, THE INABILITY OF THE DEVICE TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS, OR NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE STIMWAVE PRODUCT WAS NOT THE SOURCE OF THE ISSUE. THE ROOT CAUSE IS LIKELY DUE TO POOR ANCHORING TECHNIQUE, HOWEVER INVESTIGATION EFFORTS COULD NOT CONFIRM IT. 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 RISK MANAGEMENT FILE. STIMWAVE WAS IN CONSTANT CONTACT WITH THE TERRITORY MANAGER FROM DECEMBER 16, 2019, ONWARD REGARDING THE COMPLAINT AND THE ROOT CAUSE INVESTIGATION. STIMWAVE CONFIRMED THAT THE IMPLANT PROCEDURE DETAILS STEPS TO MITIGATE MIGRATION, AND THAT THE PRODUCT DID NOT FAIL TO MEET PERFORMANCE AND SAFETY SPECIFICATIONS. STIMWAVE HAS INFORMED ALL PARTIES THAT THE PRODUCT WAS NOT THE SOURCE 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 THE EVENT RESULTED IN A SERIOUS INJURY THAT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT OR PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE. THIS EVENT WAS REPORTED TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) ON JANUARY 8, 2020.