FREEDOM SPINAL CORD STIMULATOR

Description of Event or Problem

THE PATIENT REPORTEDLY DEVELOPED A STAPHYLOCOCCUS INFECTION DURING AN UNRELATED MINOR SURGICAL PROCEDURE ON (B)(6) 2026 THAT SPREAD TO THE ELECTRODES. CULTURES WERE OBTAINED AND AN INFECTION WAS CONFIRMED, ANTIBIOTICS WERE PRESCRIBED, AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2026. THERE WERE NO ALLEGED DEFICIENCIES AND THE PATIENT HAD PERFECT RESULTS WITH THEIR DEVICES. NO FURTHER ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE SURGICAL ISSUE QUESTIONNAIRE WAS REVIEWED FOR POTENTIAL CAUSES OF THE REPORTED ISSUE. BASED ON THIS REVIEW, IMPLANTING THE DEVICE AFTER THE EXPIRATION DATE, NOT PREPPING THE SURFACE OF THE SKIN WITH AN ANTISEPTIC SOLUTION, NOT IRRIGATING THE INCISION SITE WITH AN ANTIBIOTIC SOLUTION BEFORE CLOSURE, MULTIPLE TUNNELING ATTEMPTS, USING INCORRECT TOOLS, AND NOT USING ANTIBIOTICS PRE-OPERATIVELY HAVE BEEN RULED OUT. HOWEVER, THE PATIENT CONTRACTED A STAPHYLOCOCCUS INFECTION DURING AN UNRELATED MINOR SURGICAL PROCEDURE. THERE WERE NO ALLEGED DEFICIENCIES ASSOCIATED WITH THE CURONIX DEVICES. A CURONIX REPRESENTATIVE CONDUCTED A REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOT; CURONIX HAS CONFIRMED THAT THE PRODUCT WAS DELIVERED STERILE, VALIDATED STERILIZATION PARAMETERS WERE USED, AND STERILE BARRIERS WERE VERIFIED TO BE INTACT FOLLOWING PACKAGING. THE STIMULATOR IS USED TO TREAT PAIN. THE AS-ANALYZED CODE WAS SELECTED AS UNRELATED TO THE CURONIX DEVICE AS THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION DURING AN UNRELATED MINOR SURGICAL PROCEDURE (NO FAULT FOUND). RATES REVIEWED AT THE MOST RECENT COMPLAINT TRENDING MEETING DO NOT INDICATE A SIGNIFICANT INCREASE IN SURGICAL ISSUES. SURGICAL ISSUE RATES REMAIN ACCEPTABLY LOW; THUS, A CAPA IS NOT REQUIRED AT THIS TIME. SURGICAL ISSUE RATES WILL CONTINUE TO BE TRACKED AND TRENDED.