ReActiv8 Stimulation Lead 7M8145-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 05391527772064), received between Aug 16, 2021 and Sep 30, 2026 — classified as 22 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (143 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 178 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50952556 ↗
• MalfunctionSep 25, 2026Impedance Problem

  It was reported that the patient required magnetic resonance imaging (MRI); however, one electrode of the left lead exhibited out-of-range/high-impedance failure. The other remaining electrodes on the left lead are usable. Due to the OOR electrode, the device was explanted so the patient can have an MRI. The patient reported that the device was effective in treating low back pain and that they have not used it since 2023. Unrelated to the event, during explant, the distal tip of the lead was accidentally sheared and was left inside the patient. The physician attempted to retrieve it but was unsuccessful. The implantable pulse generator (IPG) and two leads were removed. There was no report of patient harm or injury as a result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900164 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861496 ↗
• MalfunctionSep 22, 2026Failure to Conduct; Migration

  Patient problems: Failure of Implant

  MAUDE report 50861367 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50781843 ↗
• MalfunctionSep 15, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50781162 ↗
• MalfunctionSep 15, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50781161 ↗
• MalfunctionSep 12, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50745436 ↗
• MalfunctionSep 11, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50744594 ↗
• MalfunctionSep 9, 2026Failure to Conduct

  It was reported that the patient had been without therapy from the right lead for several months before the revision procedure due to a lead fracture. During this period, the patient was programmed for unilateral stimulation and reported a return of pain symptoms.The patient subsequently underwent a lead revision procedure. The fractured right lead was explanted in its entirety and replaced with a new lead without complications. The patient reported no harm or injury.The hospital discarded the explanted lead; therefore, product analysis could not be performed. As a result, the root cause of the reported lead fracture could not be determined. The device history record (DHR) was reviewed. No relevant nonconformances were found.Following the revision procedure, the ReActiv8 system was activated, allowing the patient to initiate bilateral stimulation.

  Patient problems: Failure of Implant

  MAUDE report 50685203 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient went to the emergency room (ER) due to an infection in the midline incision with pus. A neurosurgeon on call explanted the device. Mainstay Medical Limited (MML) representative was not notified until after the explant. MML was advised that the implantable pulse generator (IPG) and two leads were removed without complications. It is unknown whether a culture was taken to confirm the type of infection or whether the patient was treated with antibiotics. No other information was available, and no devices were returned for evaluation. The IPG and lead device history records, including sterilization, were reviewed. No relevant nonconformances were found.

  Patient problems: Unspecified Infection

  MAUDE report 50095379 ↗
• MalfunctionJul 31, 2026Failure to Conduct

  Patient problems: Failure of Implant

  MAUDE report 50095378 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL ON AN UNKNOWN DATE THAT RESULTED IN A JARRING IMPACT TO HIS BACK. FOLLOWING THE FALL, THE PATIENT REPORTED PAIN ON BOTH SIDES OF THE LOWER SPINE AFTER THERAPY SESSIONS. PRIOR TO THE FALL, THE PATIENT HAD REPORTEDLY BEEN RESPONDING WELL TO THERAPY. IN RESPONSE TO THE REPORTED PAIN, THE CLINICAL SPECIALIST REDUCED THE THERAPY SETTINGS AND INSTRUCTED THE PATIENT ON PROPER POSITIONING DURING THERAPY. AN X-RAY WAS SUBSEQUENTLY PERFORMED AND CONFIRMED THAT NO LEAD MIGRATION HAD OCCURRED AS A RESULT OF THE FALL. DUE TO THE ONGOING PAIN, THE PATIENT'S THERAPY USE BECAME INCONSISTENT, AND THE PATIENT ULTIMATELY ELECTED TO HAVE THE DEVICE EXPLANTED. DURING THE EXPLANT PROCEDURE, THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE REMOVED. HOWEVER, THE RIGHT DISTAL ELECTRODE FRACTURED DURING REMOVAL AND WAS RETAINED IN THE PATIENT. THE PHYSICIAN ELECTED TO LEAVE THE FRAGMENT IN PLACE TO AVOID CAUSING ADDITIONAL MUSCLE DAMAGE. NO PATIENT INJURY OR ADVERSE CLINICAL EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25791872 ↗
• MalfunctionJul 1, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INITIATE THERAPY SESSIONS. THE CLINICAL SPECIALIST PERFORMED TROUBLESHOOTING WITH THE PATIENT AND IDENTIFIED THAT ALL ELECTRODES ON THE LEFT LEAD WERE OUT OF RANGE/HAD HIGH-IMPEDANCE READINGS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. AS A RESULT, THE PATIENT UNDERWENT SCHEDULED REVISION SURGERY TO REPLACE THE LEFT LEAD. THE IMPLANTING PHYSICIAN DECIDED TO REPLACE BOTH LEADS. THE RIGHT LEAD WAS FUNCTIONAL BUT WAS REPLACED ONLY AS A PRECAUTION. THE END CAP OF THE RIGHT LEAD REMAINED IN THE PATIENT DURING THE EXPLANT. REPORTEDLY, UNRELATED TO THE ALLEGED MALFUNCTION, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RELOCATED FROM THE RIGHT BUTTOCK TO THE RIGHT FLANK AS A PRECAUTIONARY MEASURE. THERE WAS NO ALLEGED ISSUE OR PRODUCT DEFICIENCY WITH THE IPG. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: Failure of Implant

  MAUDE report 25674925 ↗
• MalfunctionJun 10, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO START THERAPY. THERE WAS NO PATIENT HARM OR INJURY. THE CLINICAL SPECIALIST CONFIRMED THAT ALL IMPEDANCE VALUES WERE HIGH OR OUT-OF-RANGE. AS A RESULT, REVISION SURGERY WAS SCHEDULED. THE POST-INITIAL IMPLANT IMAGING REVIEW DETERMINED THAT THE LEFT LEAD WAS OUT-OF-RANGE (OOR) DUE TO A LATERAL ENTRY POINT, WHICH LIKELY CONTRIBUTED TO SIGNIFICANT MECHANICAL FATIGUE AND SUBSEQUENT LEAD FRACTURE. DURING THE REVISION PROCEDURE, IT WAS DETERMINED THAT THE LEFT LEAD WAS FRACTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE SEVERED LEFT LEAD; HOWEVER, THE LEAD WAS FIRMLY ADHERENT. DURING EXTRACTION EFFORTS, THE LEAD FRACTURED FURTHER. AS A RESULT, THE DISTAL TIP OF THE LEFT LEAD COULD NOT BE RETRIEVED AND REMAINS INSIDE THE PATIENT. THE PHYSICIAN ELECTED TO LEAVE THE RETAINED LEAD FRAGMENTS IN PLACE AND PROCEEDED WITH IMPLANTATION OF A NEW LEAD. NO EXPLANT RELEASE TOOL WAS USED DURING THE LEAD REMOVAL ATTEMPT. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). THE DEFECTIVE LEAD WAS DISCARDED AT THE FACILITY, AND THEREFORE, NO ACTUAL DEVICE EVALUATIO

  Patient problems: Failure of Implant

  MAUDE report 25452856 ↗
• InjuryJun 10, 2026Migration

  THE PATIENT REPORTED BEING UNABLE TO FEEL THE THERAPY. X-RAYS WERE TAKEN AND CONFIRMED THAT THE LEADS HAD MIGRATED FROM THE BILATERAL L3 TRANSVERSE PROCESSES. REPORTEDLY, THE PATIENT HAS A HIGH BODY MASS INDEX (BMI) AND HAS DIFFICULTY GETTING AROUND AND GETTING UP FROM SITTING. A REVIEW OF THE INTRAOPERATIVE IMAGING AND POST-IMPLANT IMAGING CONFIRMED THAT BOTH LEADS WERE DISPLACED. THERE WAS A DIFFERENCE IN LOOP LOCATION BETWEEN INTRAOPERATIVE IMAGING AND POST-FLUORO IMAGING, WITH THE LOOP AND RESULTING LEAD PULLED DOWN AN ENTIRE 1-2 LEVELS WHEN THE PATIENT WAS STANDING. THE LOOP LIKELY MOVED WITH THE SKIN, DISPLACING BOTH LEADS DUE TO THE LARGE BMI. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE TWO LEADS. BOTH LEADS WERE REMOVED COMPLETELY, AND TWO NEW LEADS WERE IMPLANTED WITHOUT COMPLICATIONS. THERE WERE NO FUNCTIONAL ISSUES WITH THE REMOVED LEADS, AND THEY WERE DISCARDED AT THE FACILITY. THEREFORE, NO ACTUAL DEVICE EVALUATION COULD BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452855 ↗
• InjuryMay 20, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION TO REPLACE THE RIGHT LEAD DUE TO AN OUT-OF-RANGE ELECTRODE, CONSISTENT WITH A HIGH-IMPEDANCE FAILURE. THE SYSTEM IS PROGRAMMABLE TO ANOTHER WORKING ELECTRODE; HOWEVER, THE PATIENT REQUIRED MAGNETIC RESONANCE IMAGING (MRI), SO THE LEAD WAS REPLACED. THE ENTIRE LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. UNRELATED TO THE OOR FAILURE, THE PATIENT REQUESTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BE MOVED TO THE FLANK AREA WHILE IN PROCEDURE. NO ALLEGATION OF AN IPG DEFICIENCY OR DISCOMFORT IN THE CURRENT IPG POCKET SITE. THE PROCEDURE WAS SUCCESSFUL WITHOUT COMPLICATIONS. THE EXPLANTED LEAD WAS DISCARDED AT THE HOSPITAL, AND THEREFORE, NO ACTUAL DEVICE ANALYSIS CAN BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND. FOLLOWING THE LEAD REVISION AND IPG RELOCATION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: Failure of Implant

  MAUDE report 25235307 ↗
• MalfunctionMay 14, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO RUN THERAPY SESSIONS. THE CLINICAL SPECIALIST CONFIRMED THAT ALL THE ELECTRODES ON THE LEFT LEAD WERE OUT OF RANGE/HIGH IMPEDANCE. THE PATIENT WAS PROGRAMMED FOR UNILATERAL STIMULATION ON THE RIGHT WHILE AWAITING SCHEDULING OF THE REVISION PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEFT LEAD. THE LEFT LEAD WAS REMOVED, WITH THE END TIP LEFT INSIDE THE PATIENT, AND A NEW LEAD WAS IMPLANTED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED AS A PRECAUTION ONLY BECAUSE OF ITS AGE (4 YEARS). THE PROCEDURE WAS COMPLETE AND WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. FOLLOWING THE LEAD AND IPG REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). ALTHOUGH REQUESTED, NO PARTS WILL BE RETURNED FOR EVALUATION, AS THE HOSPITAL STAFF KEPT THE REMOVED PARTS AND DISCARDED THEM. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: Failure of Implant

  MAUDE report 25174200 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MIDLINE INCISION WAS NOT FULLY HEALED. ONE LEAD WAS EXPOSED OUTSIDE THE PATIENT'S BODY. THE PATIENT WAS A FORMER SMOKER AND DIABETIC. THE PATIENT UNDERWENT FULL SYSTEM REVISION SURGERY. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE TWO LEADS WERE COMPLETELY REMOVED. NEW IPG AND TWO LEADS WERE IMPLANTED WITHOUT COMPLICATIONS. THERE WAS NO ALLEGATION REGARDING THE DEVICE'S FUNCTIONALITY. THE IPG AND LEADS WERE RETURNED FOR ANALYSIS. THE IPG PASSED FUNCTIONAL TESTING. BOTH LEADS WERE RECEIVED CUT INTO TWO SEGMENTS. NO FUNCTIONAL TESTING COULD BE PERFORMED. VISUAL INSPECTION OF BOTH LEADS AND THE IPG REVEALED NO OTHER DAMAGES OR ANOMALIES. FOLLOWING THE FULL SYSTEM REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: Impaired Healing

  MAUDE report 25059600 ↗
• MalfunctionApr 22, 2026Failure to Conduct

  IT WAS REPORTED THAT DURING THE PATIENT'S FOLLOW-UP VISIT. IT WAS NOTICED THAT ONE ELECTRODE ON THE RIGHT LEAD WAS OUT OF RANGE (OOR)/ HIGH IMPEDANCE ISSUE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT WAS REPROGRAMMED AND WAS ABLE TO RUN BILATERAL STIMULATION. THE PATIENT REPORTED SHE WAS RESPONDING WELL TO THE THERAPY; HOWEVER, THE PATIENT LATER DECIDED TO HAVE AN EXPLANT RATHER THAN A REVISION PROCEDURE DUE TO OTHER HEALTH ISSUES (NOT RELATED TO THE REACTIV8 SYSTEM) REQUIRING HER TO UNDERGO MAGNETIC RESONANCE IMAGING (MRI). THE IMPLANTABLE PULSE GENERATOR AND LEADS WERE COMPLETELY REMOVED WITHOUT COMPLICATIONS. THE EXPLANTED DEVICES WERE DISCARDED AT THE HOSPITAL; THEREFORE, ACTUAL DEVICE ANALYSIS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960530 ↗
• MalfunctionApr 18, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE RIGHT LEAD DUE TO ONE OF THE ELECTRODES BEING OUT OF RANGE (OOR/HIGH-IMPEDANCE FAILURE). NO IMPACT ON THE PATIENT OR THERAPY BECAUSE THE ELECTRODE WAS NOT SET FOR THERAPY. A NEW LEAD WAS IMPLANTED WITHOUT COMPLICATIONS. NO PART WAS RETURNED FOR EVALUATION. THEREFORE, NO ACTUAL DEVICE EVALUATION COULD BE PERFORMED. THE POST-IMPLANT IMAGING WAS REVIEWED, AND IT WAS CONFIRMED THAT THE OOR WAS CAUSED BY AN IMPROPER IMPLANT TECHNIQUE. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919264 ↗
• MalfunctionApr 16, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO RUN THERAPY SESSIONS. THE CLINICAL SPECIALIST CONFIRMED THAT THE ENTIRE LEFT LEAD WAS OUT OF RANGE OR HAD A HIGH-IMPEDANCE FAILURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS REPROGRAMMED TO UNILATERAL STIMULATION UNTIL REVISION SURGERY COULD BE SCHEDULED.THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE LEFT LEAD. THE ENTIRE LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED WITHOUT COMPLICATION.

  Patient problems: Failure of Implant

  MAUDE report 24901303 ↗
• MalfunctionApr 15, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO START THE THERAPY SESSION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE CLINICAL SPECIALIST TROUBLESHOT THE ISSUE WITH THE PATIENT AND CONFIRMED THAT ALL LEFT-LEAD ELECTRODES WERE OUT OF RANGE (OOR)? HIGH IMPEDANCE FAILURE. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE LEFT LEAD. THE ENTIRE LEFT LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED WITHOUT COMPLICATIONS. THE POST-INITIAL IMPLANT IMAGING WAS REVIEWED, AND THE OOR WAS LIKELY DUE TO THE LATERAL ENTRY POINT IN FASCIA.

  Patient problems: Failure of Implant

  MAUDE report 24891280 ↗
• MalfunctionApr 8, 2026Failure to Conduct

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO START THERAPY SESSIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE CLINICAL SPECIALIST TROUBLESHOT THE ISSUE WITH THE PATIENT AND CONFIRMED OUT-OF-RANGE/HIGH-IMPEDANCE READINGS ON THE LEFT LEAD. THE DEVICE WAS REPROGRAMMED TO UNILATERAL STIMULATION ON THE RIGHT SIDE ONLY, WHILE A REVISION SURGERY COULD BE SCHEDULED. THE PATIENT WAS ABLE TO INITIATE THERAPY. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE LEFT LEAD. DURING THE REVISION OF THE LEFT LEAD, THE RIGHT LEAD SHOWED HIGH IMPEDANCE ON ONE ELECTRODE. BOTH LEADS WERE REMOVED COMPLETELY, AND TWO NEW LEADS WERE IMPLANTED WITHOUT COMPLICAITONS.

  Patient problems: Failure of Implant

  MAUDE report 24818989 ↗
• InjuryApr 8, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SECONDARY SURGERY TO REMOVE THE LEAD FRAGMENTS LEFT IN THE PATIENT. THE PATIENT WAS HAVING THE REACTIV8 SYSTEM REMOVED DUE TO NO IMPROVEMENT IN PAIN. DURING THE EXPLANT, IT WAS NOTED THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF SCAR TISSUE SURROUNDING BOTH LEADS. AFTER PROLONGED ATTEMPTS AT REMOVAL, ONE LEAD FRACTURED. ALL DEVICES WERE REMOVED, EXCEPT FOR THE LEAD FRAGMENT, WHICH WAS LEFT IN PLACE. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND RESCHEDULED THE PATIENT FOR THE SECONDARY PROCEDURE TO REMOVE THE LEAD FRAGMENT. THE REMOVAL WAS SUCCESSFUL AND WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812490 ↗