ReActiv8 IPG 7M5100-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 05391527770015), received between Aug 16, 2022 and Sep 29, 2026 — classified as 172 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938600 ↗
• InjurySep 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort

  MAUDE report 50832347 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50809132 ↗
• MalfunctionSep 17, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50809131 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50809130 ↗
• InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50745437 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50744597 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  The patient underwent a surgical procedure to explant the ReActiv8 system due to a device site infection. Prior to the onset of the infection, the patient had experienced a positive therapeutic response. However, the infection resulted in painful stimulation at the implantable pulse generator (IPG) site, necessitating removal of the system. Culture was taken. No results provided to Mainstay Medical Limited. During the explant procedure, the IPG and left lead were successfully removed intact. However, two electrodes from the right lead remained inside the patient. During extraction, the right lead was inadvertently damaged by a surgical instrument (artery clip), causing the lead to kink. The physician subsequently cut the lead proximal to the damaged section, which limited access to the distal end and left the remaining lead segment insufficiently rigid for complete removal. Despite multiple extraction attempts, the right lead fractured, resulting in retention of two electrodes.No patient harm or injury was reported as a result of this event. The explanted devices were disposed of by the facility and were therefore unavailable for evaluation. Device history records for the IPG and l

  Patient problems: Unspecified Infection

  MAUDE report 50168136 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced discomfort at the implantable pulse generator (IPG) pocket site. There was no report of patient harm or injury. As a result, the patient underwent surgery. The IPG was relocated from the right flank to the right upper buttock without complications. The device remains implanted and functional.

  Patient problems: Implant Pain

  MAUDE report 50074170 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced discomfort in the implantable pulse generator (IPG) pocket site. The discomfort started soon after the initial implant. There was no allegation of a product deficiency. The IPG and leads were removed without complications. There was no report of patient harm or injury.

  Patient problems: Implant Pain

  MAUDE report 50074164 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The Mainstay Medical Limited (MML) representative received information from the physician that the patient developed a confirmed infection, which led to the explantation of the ReActiv8 system. No MML representative was present during the explant procedure.According to the physician, the infection originated at the implantable pulse generator (IPG) site. The patient was treated with antibiotics; however, the infection subsequently spread to the lead midline incision. The specific antibiotic administered was not disclosed. As a result of the infection, the physician elected to explant the entire system, including the IPG and all leads. Although the infection was confirmed, the physician did not provide the infection type.During device removal, one lead fractured; however, the physician successfully retrieved the remaining lead fragment. No explant tool was used during the procedure.The explanted IPG and leads were not returned to MML; therefore, no device evaluation could be performed. A review of the device history record, including sterilization records, was conducted and identified no relevant nonconformances.

  Patient problems: Unspecified Infection

  MAUDE report 50003349 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER, AND THE WOUNDS WERE RED, HOT, AND TENDER ON PALPATION OF BOTH INCISIONS FOLLOWING THE LEAD REVISION PROCEDURE ON (B)(6) 2026. REFERENCE: MFG REPORT # 3021520203-2026-0076. THERE WAS DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THERE WERE NO SIGNS OF INFECTION DURING THE DEVICE ACTIVATION POST-REVISION PROCEDURE ON (B)(6) 2026. THE PATIENT WAS TREATED WITH ANTIBIOTICS (INTRAVENOUS AND ORAL). BLOOD AND CULTURES WERE TAKEN, CONFIRMING INFECTION. THE TYPE OF INFECTION WAS NOT DISCLOSED TO MAINSTAY MEDICAL LIMITED (MML). AS A RESULT, THE DEVICE WAS EXPLANTED, AND WOUND WASHOUT WAS PERFORMED. THE IPG AND LEADS WERE SUCCESSFULLY REMOVED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE LEADS WERE KEPT BY THE HOSPITAL FOR CULTURE ANALYSIS. THE IPG AND LEAD DEVICE HISTORY RECORDS, INCLUDING STERILIZATION, WERE REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Unspecified Infection

  MAUDE report 25788597 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE DUE TO SUPERFICIAL IPG PLACEMENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT UNDERWENT REVISION SURGERY, AND THE PHYSICIAN REPOSITIONED THE IPG TO A MORE COMFORTABLE POSITION AND IMPLANTED IT MORE DEEPLY. THE PROCEDURE WAS SUCCESSFUL WITHOUT COMPLICATION. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL. THERE WERE NO ALLEGATIONS REGARDING THE DEVICE'S FUNCTIONALITY. FOLLOWING THE IPG REPOSITIONING, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: Implant Pain

  MAUDE report 25673226 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WITH SWELLING AND REDNESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PHYSICIAN PERFORMED A POCKET SITE WASHOUT. THE PATIENT WAS TREATED WITH ANTIBIOTICS- UNKNOWN WHETHER ORAL OR IV ANTIBIOTICS. THE TYPE OF INFECTION IS UNKNOWN, AND IT IS UNCLEAR WHETHER A CULTURE WAS PERFORMED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL. THE DEVICE HISTORY RECORD, INCLUDING THE STERILIZATION PROCESS, WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Unspecified Infection

  MAUDE report 25472225 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT STATED THAT THE DEVICE WOULD TILT OR PROTRUDE ON THE SUPERIOR ASPECT WHEN STANDING. THE PATIENT FURTHER REPORTED A FALL APPROXIMATELY ONE YEAR AGO; BUT PRIOR TO THAT, THE POCKET SITE HAD BEEN ACHY FOR SEVERAL MONTHS. FOLLOWING THE REPORTED FALL, THE DISCOMFORT TEMPORARILY WORSENED, COINCIDING WITH THE DEVICE APPEARING TO PROTRUDE FROM THE BACK. THE PATIENT INDICATED THAT THE DISCOMFORT SUBSEQUENTLY RESOLVED. THE PATIENT ALSO REPORTED WEIGHT GAIN BUT DID NOT SPECIFY THE AMOUNT. THE PATIENT REPORTED THAT THERAPY HAD BEEN EFFECTIVE, PROVIDING RELIEF FROM BACK PAIN OVER APPROXIMATELY ONE YEAR OF USE. THE PATIENT ELECTED EXPLANT RATHER THAN REVISION DUE TO IMPROVEMENT OF BACK PAIN. THERE WERE NO REPORTED ISSUES WITH DEVICE PERFORMANCE OR THERAPY DELIVERY. THE IPG AND ASSOCIATED LEADS WERE EXPLANTED WITHOUT COMPLICATION. THERE WAS NO REPORT OF PATIENT INJURY, ADVERSE HEALTH CONSEQUENCES, OR CLINICAL HARM ASSOCIATED WITH THIS EVENT. NO ALLEGATION OF PRODUCT DEFICIENCY WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND WAS DISPOSED OF AT THE FACILITY; THEREFOR

  Patient problems: Implant Pain

  MAUDE report 25465020 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AROUND THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT HAS A LOW BODY MASS INDEX (BMI), WHICH CAUSES THE SKIN TO STRETCH. THE PATIENT REQUESTED AN EXPLANT. THE IPG AND TWO LEADS WERE COMPLETELY REMOVED WITHOUT COMPLICATIONS. ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED DUE TO FACILITY POLICY. NO ACTUAL DEVICE EVALUATION CAN BE PERFORMED. THE IPG AND LEADS DEVICE HISTORY RECORDS WERE REVIEWED. NO NONCONFORMANCES WERE FOUND.

  Patient problems: Implant Pain

  MAUDE report 25415668 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE EXACT ONSET DATE OF THE INFECTION IS UNKNOWN, BUT REDNESS, SWELLING, AND DEHISCENCE WERE REPORTED AT THE IPG POCKET SITE. NO PRODUCT DEFICIENCY WAS REPORTED, AND THE PRODUCT WAS WORKING AS INTENDED. THE PATIENT WAS TREATED WITH ANTIBIOTICS (ORAL AND IV) AND UNDERWENT WOUND WASHOUT. IT IS UNKNOWN WHETHER A CULTURE WAS TAKEN AND WHAT THE RESULTS WERE. THE ENTIRE IPG AND LEADS WERE REMOVED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO FACILITY POLICY. HOWEVER, THE DEVICE HISTORY RECORDS AND STERILIZATION PROCESS WERE REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Wound Dehiscence; Wound Infection

  MAUDE report 25415534 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA AND POSSIBLE INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. REPORTEDLY, THE IPG POCKET WAS DEHISCENT. A CULTURE WAS TAKEN BUT CAME BACK NEGATIVE FOR BACTERIA/INFECTION. NO PRODUCT DEFICIENCY WAS REPORTED. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE PHYSICIAN CLEANED THE SURGICAL SITES, WASHED OUT THE IPG POCKET SET, AND IMPLANTED THE IPG MORE DEEPLY TO PREVENT A SEROMA. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL. THE DEVICE HISTORY RECORDS AND STERILIZATION PROCESS WERE REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 25415408 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT REPORTED THAT THE THERAPY WAS EFFECTIVE AND PROVIDED RELIEF FROM BACK PAIN; HOWEVER, THE PATIENT REQUESTED AN EXPLANT WHILE COVERED UNDER THE STUDY FUNDING. THERE WAS NO ALLEGATION OF A PRODUCT DEFICIENCY, AND THE PATIENT REPORTED THAT THERAPY WAS SUCCESSFUL, ENABLING THEM TO EXERCISE AND IMPROVE SPINAL STABILITY. THE IPG AND LEADS WERE REMOVED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO DEVICE WAS RETURNED FOR ANALYSIS PER FACILITY POLICY; THEREFORE, NO DEVICE EVALUATION COULD BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCE'S WERE FOUND.

  Patient problems: Implant Pain

  MAUDE report 25399572 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED LOSING WEIGHT, AND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD BECOME SUPERFICIAL AND WAS CAUSING DISCOMFORT AT THE IPG POCKET SITE. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE DEVICE IS WORKING AS INTENDED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT REQUESTED AN EXPLANT. THE ENTIRE LEADS AND IPG WERE SUCCESSFULLY EXPLANTED WITHOUT COMPLICATIONS. ALTHOUGH REQUESTED, THE LEADS AND IPG WERE DISPOSED OF AT THE FACILITY. NO DEVICE EVALUATION COULD BE PERFORMED. THE LEADS AND IPG DEVICE HISTORY RECORDS WERE REVIEWED. NO RELEVANT NONCONFORMANCE'S WERE IDENTIFIED.

  Patient problems: Implant Pain

  MAUDE report 25273587 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  MAINSTAY MEDICAL LIMITED (MML) RECEIVED INFORMATION THAT THE DEVICE WAS EXPLANTED DUE TO PERSISTENT OOZING FROM THE WOUND AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. NO MML REPRESENTATIVE WAS PRESENT DURING THE DEVICE EXPLANT. HOWEVER, THE ENTIRE REACTIV8 SYSTEM WAS REPORTED TO HAVE BEEN REMOVED WITHOUT COMPLICATIONS. A CULTURE WAS TAKEN, BUT THE RESULTS WERE NOT PROVIDED TO MML. IT IS ALSO UNKNOWN IF THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS NEVER SWITCHED ON POST-IMPLANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO ACTUAL DEVICE ANALYSIS COULD BE PERFORMED. HOWEVER, THE DEVICE HISTORY RECORD, INCLUDING STERILIZATION, WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE ALLEGED WOUND-HEALING ISSUE.

  Patient problems: Impaired Healing

  MAUDE report 25174201 ↗
• InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED GENERAL DISCOMFORT IN THE IMPLANTABLE PULSE GENERATOR (IPG) AREA DUE TO THE BATTERY PUSHING AGAINST THE SKIN. THE IPG WAS SITTING FLAT AND WAS PROTRUDING. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE IPG. A NEW IPG WAS IMPLANTED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT HARM OR INJURY. THE IPG WAS RETURNED FOR ANALYSIS. THE IPG PASSED THE FUNCTIONALITY TESTING AND PERFORMS PROPERLY. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES WITH THE RECEIVED IPG. THE DEVICE HISTORY RECORD, INCLUDING THE STERILIZATION PROCESS, WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND. FOLLOWING THE IPG REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: Discomfort

  MAUDE report 25062702 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE BENEFITED FROM THE THERAPY BUT REQUESTED AN EXPLANT DUE TO ONGOING POCKET PAIN SINCE BEING IMPLANTED WITH THE REACTIV8 SYSTEM, AND THE PATIENT WAS TREATED WITH PAIN MEDICATIONS. THE IMPLANTABLE PULSE GENERATOR (IPG) AND TWO LEADS WERE REMOVED WITHOUT COMPLICATIONS. ALL COMPONENTS WERE REMOVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT KEPT THE IPG. THEREFORE, NO PRODUCT EVALUATION COULD BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Implant Pain

  MAUDE report 25059608 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AND DECIDED TO HAVE THE DEVICE EXPLANTED. THE IPG AND LEADS WERE REMOVED COMPLETELY WITHOUT ANY COMPLICATIONS. NO REPORT OF PATIENT HARM OR INJURY. THE REACTIV8 SYSTEM IS FUNCTIONAL, AND NO ALLEGATION OF A PRODUCT MALFUNCTION; NO PARTS WERE RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Implant Pain

  MAUDE report 25000055 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE REACTIV8 SYSTEM WAS REPORTEDLY EXPLANTED DUE TO A SUSPECTED INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. A CULTURE WAS REPORTEDLY OBTAINED; HOWEVER, THE RESULTS WERE NOT PROVIDED TO MAINSTAY MEDICAL. THERE WERE NO ALLEGATIONS OF A PRODUCT DEFICIENCY. THE IPG AND LEADS WERE COMPLETELY REMOVED WITHOUT COMPLICATION. THE PATIENT WAS REPORTEDLY RECEIVING IMMUNOSUPPRESSIVE THERAPY FOR OTHER MEDICAL CONDITIONS, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE INFECTION. REPORTEDLY, THE PATIENT HAD BEEN ON ANTIBIOTICS FOR 1-2 MONTHS PRIOR TO THE EXPLANT. THE DEVICE WAS REPORTEDLY RETAINED BY THE HOSPITAL DUE TO THE NATURE OF THE EVENT; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD, INCLUDING STERILIZATION RECORDS, WAS CONDUCTED, AND NO RELEVANT NONCONFORMANCES WERE IDENTIFIED.

  Patient problems: Wound Infection

  MAUDE report 24960533 ↗