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Patient 1
STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM AN INFECTION REPORTED TO STIMWAVE ON (B)(6) 2019, BY STIMWAVE TERRITORY MANAGER. ON (B)(6) 2019, THE TERRITORY MANAGER WAS MADE AWARE THAT THE PATIENT WAS BEING TREATED BY THE IMPLANTING CLINICIAN FOR AN INFECTION AT AND AROUND THE NEEDLE ENTRY SITE OF HER IMPLANT. THE PATIENT REPORTED TO THE TERRITORY MANAGER THAT SHE WAS PRESCRIBED ANTIBIOTICS (NAME, DOSE, DURATION IS UNKNOWN) BY THE IMPLANTING CLINICIAN ON (B)(6) 2019, AND HAD AN APPOINTMENT ON (B)(6) 2019 FOR DEVICE EVALUATION AND POTENTIAL EXPLANT. ON (B)(6) 2019, THE PATIENT REPORTED THAT THE WOUND SITE WAS SHOWING SIGNS OF HEALING. ON (B)(6) 2019, THE IMPLANTING CLINICIAN RECOMMENDED DEVICE EXPLANT TO ENSURE COMPLETE HEALING. IT IS NOT KNOWN IF THE PATIENT WILL HAVE A NEW DEVICE PLACED. AS OF (B)(6) 2019, THE PATIENT REPORTED THAT THE WOUND SITE WAS NO LONGER INFLAMED, AND WAS HEALING FROM THE EXPLANT. IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY CONTACTED THE TERRITORY MANAGER TO DISCUSS THE EVENTS LEADING UP TO AWARENESS OF THE ISSUE AND TO REVIEW THE IMPLANTING CLINICIAN'S INFECTION PREVENTION PROTOCOL. THE TERRITORY MANAGER REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM ON (B)(6) 2019 IN WHICH A STIMQ STIMULATOR (STQ4-RCV-A0) WAS IMPLANTED AT THE PATIENT'S RIGHT POSTERIOR TIBIAL NERVE AND A STIMQ SPARE LEAD (STQ4-SPR-B0) WAS IMPLANTED AT THE PATIENT'S LEFT POSTERIOR TIBIAL NERVE TO TREAT THE PATIENT'S CHRONIC PAIN IN HER FEET. THE TERRITORY MANAGER CONFIRMED THAT THE IMPLANT PROCEDURE WAS PERFORMED IN A STERILE ENVIRONMENT, STERILE FIELD HANDLING PROTOCOLS WERE USED, THE PROCEDURE WAS COMPLETED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE, AND THE STERILE BARRIERS OF ALL PRODUCT USED WERE INTACT PRIOR TO IMPLANT. THERE WERE NO COMPLICATIONS EXPERIENCED DURING THE PROCEDURE AND PATIENT WAS SENT HOME THE SAME DAY. THE CLINICIAN IMPLANTED THE STIMULATOR AND REPORTED NO COMPLICATIONS OR ISSUES WITH PLACEMENT OR PROGRAMMING. THE PATIENT EXPERIENCED PAIN RELIEF AFTER THE PROCEDURE. THE TERRITORY MANAGER REPORTED THAT HE HAD MET WITH THE PATIENT ON (B)(6) 2019 FOR REPROGRAMMING, AND DID NOT OBSERVE ANY ISSUES WITH THE SURGICAL SITE. DURING THE REPROGRAMMING SESSION, THE TERRITORY MANAGER WAS NOT AWARE OF ANY ALLEGED DEFICIENCY IN THE PRODUCT WITH RESPECT TO PRODUCT IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE. THE TERRITORY MANAGER REPORTED THAT THE INFECTION WAS ONLY OBSERVED IN THE RIGHT LEG, AT OR AROUND THE SUTURE SITE, AND THE PATIENT WAS CONTINUING TO USE THE STIMQ PNS SYSTEM TO TREAT THE PAIN. WHILE THE WOUND SITE WAS CULTURED, THE RESULTS OF THIS TEST ARE UNKNOWN TO STIMWAVE. BECAUSE THE INFECTION WAS ONLY PRESENT IN ONE LEG, AND NOT BOTH, THE IMPLANTING CLINICIAN SUSPECTED THAT THE PATIENT MIGHT HAVE INADVERTENTLY CAUSED OR CONTRIBUTED TO THE ISSUE, BY SCRATCHING OR OTHERWISE IRRITATING THE NEEDLE ENTRY SITE. TO RULE OUT ANY POTENTIAL ISSUES WITH PRODUCT STERILITY, STIMWAVE REVIEWED STERILIZATION RECORDS ON PRODUCT FROM INVENTORY, WHICH CONFIRMED STIMULATORS FROM THE SAME LOT ARE STERILE OUT OF THE PACKAGE. THE TERRITORY MANAGER ALSO CONFIRMED THAT ON THE DAY OF THE IMPLANT THE PRODUCT PACKAGING WAS NOT DAMAGED, AND THE STERILE BARRIER REMAINED INTACT PRIOR TO THE IMPLANT. THE RAW DATA FROM STERILIZATION CYCLE MATCHED THE CYCLE SPECIFICATION. STIMWAVE QUALITY, ENGINEERING, AND MANUFACTURING VERIFIED THAT THE CORRECT CYCLE SPECIFICATION WAS USED FOR THE STIMULATOR LOT. THE SOURCE OF THE ISSUE WAS NOT TRACED BACK TO COMPROMISED PRODUCT STERILITY OR OPERATING ROOM CONDITIONS. STIMWAVE REVIEWED THE LOT HISTORY DISTRIBUTION, AND NO TRENDS OF INFECTIONS WERE NOTED. SURGICAL SITE INFECTION IS A KNOWN COMPLICATION OF SURGERY. THE SOURCE OF THE ISSUE IS LIKELY ATTRIBUTED TO THE PATIENT'S SUSCEPTIBILITY TO INFECTION DUE TO PRE-EXISTING CONDITIONS, SURGICAL HISTORY, AND POTENTIAL NONCOMPLIANCE TO INFECTION PREVENTION FOLLOWING A SURGICAL PROCEDURE. THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. AT THIS TIME, IT IS UNDETERMINED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE ISSUE. HOWEVER, IT IS LIKELY ATTRIBUTED TO PATIENT CONSTANTLY ITCHING AND PICKING THE SITE OF THE WOUND, PERSONAL HYGIENE, OR HOME ENVIRONMENT. THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATION. STIMWAVE WILL CONTINUE TO TRACK AND TREND EVENTS. THE SOURCE OF THE ISSUE WAS NOT TRACED BACK TO COMPROMISED PRODUCT STERILITY OR OPERATING ROOM CONDITIONS. AS OF (B)(6) 2019, THE PATIENT REPORTED SIGNIFICANT RELIEF OF HER PAIN IN HER LEFT LEG, REPORTED NO OTHER ISSUES OR ADVERSE EVENTS, AND IS INTERESTED IN A NEW DEVICE TO REPLACE THE ONE EXPLANTED PROPHYLACTICALLY. THE ROOT CAUSE OF THE COMPLAINT IS NOT ATTRIBUTED TO DEVICE FAILURE OR INABILITY TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. THE ROOT CAUSE IS LIKELY ATTRIBUTED TO PATIENT ITCHING AND PICKING THE SITE OF TH...