Axonics 5101Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 10810005340479), received between Aug 24, 2023 and Sep 29, 2026 — classified as 152 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Migration” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Discomfort; Inadequate Pain Relief; Inappropriate Device Stimulation of Tissue

  MAUDE report 50941280 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Dehiscence

  MAUDE report 50941186 ↗
• InjurySep 29, 2026Charging Problem; Migration

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain; Paresthesia; Weight Changes

  MAUDE report 50941052 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50938827 ↗
• InjurySep 4, 2026High impedance; Communication or Transmission Problem

  It was reported that the patient with a Rechargeable SNM IPG had a red-light error on their remote that would not clear. All high (open) impedances were discovered, and the error could not be cleared in clinic. A successful revision was done on the patient, with both lead and battery replaced. The patient was doing well post procedure. No patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614759 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with the neurostimulator (INS) experienced painful "zapping" sensations when turning stimulation off on three separate occasions, including before two MRI procedures and a low back ablation. During the most recent MRI on (b)(6) 2026, the sensation was reported as significantly more painful. After stimulation was turned back on following the MRI, they continued to experience intermittent zapping while walking and bending over. They turned stimulation off again on (b)(6) 2026, after which the zapping resolved. The sensation was localized approximately three to four inches above and slightly to the right of the implanted neurostimulator in the right buttock. They were unsure whether the sensation was related to the device or a back nerve issue and reported no red light on the remote. Troubleshooting consisted of turning stimulation off, which resolved the issue. The patient was met in the office to troubleshoot. The physician considered the device's contribution to the undesired stimulation and pain to be unknown. When connected with the Clinician Programmer (CP), there was no error message. However, it did cause significant pain, as they felt a strong

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50609793 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50599932 ↗
• InjurySep 3, 2026Unexpected Therapeutic Results; Charging Problem

  Patient problems: Discomfort; Implant Pain; Inflammation

  MAUDE report 50599755 ↗
• InjuryAug 31, 2026Charging Problem

  It was reported that the patient with this Neurostimulator (INS) was unable to charge their implant. The patient said this has been happening since last year. Troubleshooting attempts were made but was unsuccessful. The patient denied any injuries; however, the patient does have other medical conditions, but it is not confirmed if it contributed to the patient having difficulty to charge. The patient needed an MRI and had not been able to due to the patient not being able to charge their implant. Afterward, the patient had surgery to explant their INS and Tined Lead. The patient reported they are doing fine post-explant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515506 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with a Rechargeable SNM IPG reported that the therapy did not work like they had wanted. The patient was given a new Program 1 and initially reported improvement. During follow up the patient stated that symptom relief was temporary and typically lasted only two days before symptoms returned. The patient further noted that the therapy did not meet expectations for complete symptom resolution and determined that medication provided more consistent symptom improvement. The device was explanted and the patient was stable postoperatively.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515485 ↗
• InjuryAug 24, 2026High impedance; Communication or Transmission Problem

  It was reported that a patient with a Rechargeable SNM IPG was experiencing pain at their battery site. The patient also noted the stimulation was inadequate. A red light was later noticed on the device; however, an impedance check was not performed. The device was explanted and the patient is stable with no reported complications.

  Patient problems: Implant Pain

  MAUDE report 50416010 ↗
• InjuryAug 19, 2026Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a Neurostimulator had their device removed as it was not working for them. There were no additional patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334641 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with a Neurostimulator had their device explanted as they felt it was ineffective in treating their urge urinary incontinence symptoms. The patient declined troubleshooting and reprogramming. The procedure was completed (b)(6) 2026. No other patient complications were reported as a result of this event.

  Patient problems: Micturition Urgency; Urinary Incontinence

  MAUDE report 50308178 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Implantable Neurostimulator (INS) experienced uncomfortable stimulation since implantation. Multiple programming adjustments were attempted without resolution. The patient reported discomfort and stimulation radiating down the leg, including during a period when stimulation was reportedly turned off. Additional information received indicated that the device was subsequently explanted. No further patient complications were reported.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 50046737 ↗
• InjuryJul 15, 2026Fracture; High impedance

  IT WAS REPORTED THE PATIENT IMPLANTED WITH THIS NEUROSTIMULATOR EXPERIENCED SHOCKING SENSATION BELOW THEIR IMPLANT SITE AND BUTTOCK AREA. THEY REPORTED THEY FELT THE SHOCKING SENSATION WHEN SITTING DOWN. THE PATIENT DENIED ANY FALLS, PROCEDURES, NOR RECEIVED IMAGING. THE PATIENT WAS ASSISTED WITH CHARGING THEIR DEVICE AND NO RED LIGHTS ON THE REMOTE CONTROL WERE PRESENT. THEN IT WAS DISCOVERED THE PATIENT HAS HIGH IMPEDANCE. THE STIMULATION WAS TURNED OFF AND THE PHYSICIAN SUBMITTED ORDERS FOR A REVISION SURGERY. ADDITIONALLY, IT WAS ULTIMATELY DECIDED THAT THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD WITH NO REPLACEMENT. ALSO, IT WAS DISCOVERED DURING EXPLANT THAT THE LEAD WAS FRAGMENTED. THE LOCAL CARE TEAM CONTACTED THE PATIENT TO DETERMINE THEIR STATUS, BUT THE PATIENT DID NOT RESPOND.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25833716 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING OOZING, REDNESS, SWELLING, AND TENDERNESS AT THE IMPLANT SITE. THE PATIENT REPORTS INTERMITTENTLY TURNING ON AND OFF THEIR IMPLANT SINCE 2025. THE PATIENT UNDERWENT AN EXPLANT DUE TO INFECTION. BOTH THE NEUROSTIMULATOR AND TINED LEAD WERE EXPLANTED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 25680091 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WITH THIS NEUROSTIMULATOR (INS) HAD AN ELECTIVE SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT STATED THEY DID NOT FEEL LIKE THEY NEEDED THE DEVICE ANYMORE AND IS MANAGING THEIR SYMPTOMS WITHOUT IT. THE PATIENT FELT LIKE THE TREATMENT WAS INCONSISTENT AND NOT EFFECTIVE. THE PATIENT HAS AN ACTIVE LIFESTYLE, AND THEY NOTICED THE IMPLANT WAS BOTHERSOME, BUT DID NOT CAUSE DISCOMFORT. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680089 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS COMPLAINING OF DISCOMFORT AT THEIR IMPLANT SITE. THE PATIENT IS CLINICALLY ANOREXIC AND HAS LOST WEIGHT RECENTLY COMPARED TO THE TIME THE IMPLANT WAS PLACED. THE PHYSICIAN AND PATIENT ELECTED TO REMOVE THE PATIENT'S IMPLANTED NEUROSTIMULATOR AND TINED LEAD. THE PATIENT HAD A FULL SYSTEM EXPLANTATION. THERE WERE NO OTHER ISSUES OR COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain; Weight Changes

  MAUDE report 25524956 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THEIR IMPLANT SITE. THE PATIENT ALSO REPORTED SPORADIC TINGLING DOWN BOTH LEGS AND FEET AND PAIN AT THE LEAD INSERTION SITE AS WELL. THE PHYSICIAN RECOMMENDED TURNING OFF THEIR DEVICE AND ORDERED AN X-RAY. ALSO, THE PHYSICIAN TOLD THE PATIENT TO CONTACT THE LOCAL CARE TEAM TO DO SOME REPROGRAMMING TO SEE IF IT COULD HELP AFTER THE X-RAY RESULTS COME BACK. THE PATIENT ALSO MENTIONED THE PHYSICIAN NOTED THE NEUROSTIMULATOR IS SLIGHTLY ELEVATED IN THE POCKET. THE PATIENT BELIEVES THE PAIN SUBSIDED AFTER TURNING OFF THEIR DEVICE AND WILL MONITOR THEIR SYMPTOMS UNTIL THE X-RAY RESULTS COME BACK AND ATTEMPT TO REPROGRAM. ADDITIONALLY, THE PATIENT HAS NOT HAD ANY OTHER TREATMENT FOR THIS EVENT. THE PATIENT HAD ALL OF THE SAME SYMPTOMS EVEN WITH THE DEVICE OFF. THEN THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD.

  Patient problems: Discomfort; Implant Pain; Inappropriate Device Stimulation of Tissue; Paresthesia

  MAUDE report 25446858 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPRESSED THAT THEY WERE HAVING INTERMITTENT, POSITIONAL PAIN AROUND THEIR DEVICE. THE PAIN WAS SHARP AND RADIATED TO THE TOP OF THEIR BUTTOCKS. THE PATIENT DENIES ANY FALLS OR IMPACTS TO THE DEVICE SITE. THE LIGHTS ON THE PATIENT'S REMOTE WERE SHOWING GREEN. THE PATIENT WAS ADVISED TO TURN OFF THEIR DEVICE WHILE THEY AWAIT CLINICAL EVALUATION. THE PATIENT TOOK OVER THE COUNTER PAIN MEDICATION TO HELP ALLEVIATE SYMPTOMS. DURING EVALUATION, THE DEVICE'S IMPEDANCES WERE NOTED TO BE WITHIN PARAMETERS. THE PATIENT STILL EXPERIENCED PAIN WHILE THE DEVICE WAS OFF. THE DEVICE WAS TURNED ON, AND THE PATIENT STATED THAT THERE WAS NO ADDITIONAL PAIN DUE TO STIMULATION. FOLLOWING CLINICAL EVALUATION, THE PATIENT CONTINUED TO HAVE SHARP PAIN. THE DEVICE WAS EXPLANTED BECAUSE OF THE PATIENT'S CONTINUED PAIN.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 25260035 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DAUGHTER REACHED OUT TO REPORT THAT THE PATIENT IS IN EXCRUCIATING PAIN IN THE LOWER BACK WHICH RADIATED DOWN THE RIGHT LEG THROUGH THE FOOT AS WELL AS LEFT LEG. THE PATIENT ALSO COMPLAINED OF VAGINAL NUMBNESS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE PATIENT HAS A HISTORY OF MVA AND SPINAL SURGERIES. THE IMPLANT IS OFF WHILE THE PHYSICIAN ORDERS TESTS TO DIAGNOSE THE ISSUE. THE PHYSICIAN BELIEVES THAT PATIENT HAS PINCHED NERVES WHICH ARE CAUSING THE PAIN AND DID NOT THINK THAT THE DEVICE WAS RELATED TO THE PATIENT'S CONDITION. THERE WERE NO OTHER ISSUES OR COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: Discomfort; Implant Pain; Numbness; Pain

  MAUDE report 25224912 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WITH THIS NEUROSTIMULATOR AND TINED LEAD HAD AN EXPLANT. THE PATIENT REPORTED THEY HAD THE EXPLANT SURGERY LAST YEAR DUE TO DISCOMFORT AND INEFFICACY. THE PATIENT SAID THEY COULD NOT REMEMBER THE EXACT DATE OF THE EXPLANT, ONLY STATED IT HAPPENED SOMETIME LAST YEAR. THE PATIENT FULLY RECOVERED AND IS NO LONGER IN DISCOMFORT. THE PATIENT IS EXPLORING OTHER TREATMENT OPTIONS.

  Patient problems: Discomfort

  MAUDE report 25208676 ↗
• InjuryMay 13, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR (INS) WAS EXPERIENCING SHOCKING SENSATIONS, HAS BEEN SENSITIVE TO STIMULATION, AND HAS NOTICEABLE BLISTERING/ABRASIONS AT THE INS SITE. THE PATIENT NOTED THAT SINCE ABOUT AUGUST, THE INS HAS STARTED SURFACING. THE PATIENT HAD MANY INSTANCES OF THE BLISTERING OPENING UP AND HEALING, BUT NO INFECTION WAS REPORTED, AND IT HAS BEEN VERY PAINFUL. THE PATIENT HAS MADE SEVERAL ER TRIPS FOR PAIN AND RETENTION. AT THESE VISITS, THEY HAVE BEEN PRESCRIBED FENTANYL AND HAS TAKEN KRATOM FOR THE PAIN AS WELL. A REVISION OF THE LEAD AND INS IS PLANNED BUT NOT YET SCHEDULED. THE PATIENT UNDERWENT A LEAD REPLACEMENT AND REVISED NEUROSTIMULATOR ON (B)(6) 2026. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Inappropriate Device Stimulation of Tissue; Pain; Rash; Urinary Retention

  MAUDE report 25164860 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) THAT THE IMPLANT DEHISCED THROUGH THE SKIN. DURING THE INITIAL IMPLANT OF THIS DEVICE, THE PATIENT HAD DIFFICULT WOUND HEALING; HOWEVER, THE WOUND EVENTUALLY HEALED. LATER ON, THE PATIENT EXPERIENCED EROSION AT THE IMPLANT SITE. THE DEVICE WAS EXPLANTED, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 25107660 ↗
• InjuryMay 5, 2026Migration

  IT WAS REPORTED THAT A PATIENT FELT LIKE THEIR IMPLANT BATTERY HAD MOVED. THE PATIENT CONTACTED THEIR PHYSICIAN AND STATED THAT THEY ALSO FELT A TUGGING SENSATION UNDER THEIR SKIN. THE PHYSICIAN THOUGHT IT COULD BE FROM THE BATTERY BEING DISPLACED AND PULLING ON THE LEAD. X-RAYS WERE DONE AND CONFIRMED THAT THE PATIENT'S IMPLANT BATTERY HAD SHIFTED IN THE POCKET. A POCKET REVISION WAS DONE ON THE PATIENT WHICH WAS SUCCESSFUL. FOLLOWING THE PROCEDURE, THE PATIENT REACHED OUT TO THEIR REPRESENTATIVE AND ADVISED THEY ARE STILL EXPERIENCING THE TUGGING SENSATION AND TENDERNESS WHEN THEY TOUCH THEIR SACRUM. THE PATIENT HAS CONTACTED THEIR PHYSICIAN ALSO CONCERNING THIS ISSUE FOR NEXT STEPS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 25085398 ↗