Axonics 1101Recalls & reported problems

Summary

The FDA's MAUDE database contains 397 adverse event reports that list this exact device (DI 10810005340066), received between Feb 28, 2020 and Sep 29, 2026 — classified as 1 death, 317 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (47 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 397 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Overheating of Device

  Patient problems: Burning Sensation; Discomfort; Implant Pain

  MAUDE report 50941018 ↗
• InjurySep 5, 2026Communication or Transmission Problem; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50624279 ↗
• InjurySep 4, 2026Overheating of Device

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50617312 ↗
• InjurySep 4, 2026Premature Discharge of Battery; Charging Problem

  It was reported that the patient with this Rechargeable SNM neurostimulator was experiencing vaginal pain whether their device was on or off. They also noted that the device was not holding a charge and they were having a hard time charging. The patient began complaining of pain that differentiated between stimulation and other sensations. The patient was comfortable and the device was reprogrammed. The patient also noted dizziness and falling, but impedances appeared fine and the patient felt their stimulation appropriately. The patient then underwent a battery replacement to a non-rechargeable battery. There were no additional patient complications.

  Patient problems: Dizziness; Fall; Inappropriate Device Stimulation of Tissue

  MAUDE report 50612252 ↗
• InjurySep 3, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600016 ↗
• InjuryAug 7, 2026Failure to Charge; Adverse Event Without Identified Device or Use Problem; Migration

  It was reported that the patient with the neurostimulator experienced a loss of symptom relief despite undergoing multiple device reprogramming sessions. Imaging was obtained and demonstrated lead migration. Based on these findings, lead revision was discussed with the patient. The patient also reported difficulty charging the neurostimulator due to limited shoulder mobility, which prevented them from consistently charging the device. As a result, battery replacement was also discussed. The patient subsequently underwent a revision procedure during which all previously implanted neurostimulation components were explanted and replaced with a new lead and an INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176319 ↗
• InjuryJul 31, 2026Premature Discharge of Battery; Charging Problem

  It was reported that the patient with the neurostimulator underwent an explant due to the battery failing to charge. The patient no longer wanted to charge their battery therefore they opted for a replacement. The device was replaced with a different model device. The patient states that they've had 2 years with issues charging the device and that the battery was dead for a while before they decided to change the model. Only the neurostimulator was revised.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099807 ↗
• InjuryJul 29, 2026Migration

  It was reported that the patient with the neurostimulator is experiencing pain at the pocket site. The device has been off for a while. The patient went to the emergency room and got a CT scan and the device shows migration. The patient underwent an explant on (b)(6) 2026.

  Patient problems: Implant Pain

  MAUDE report 50072798 ↗
• InjuryJul 29, 2026Overheating of Device

  It was reported that the patient with this Neurostimulator (INS) had surgery to remove and replace their INS and Tined Lead. The patient had been getting good symptom relief, but reported burning sensation when charging their INS. The patient had their system replaced with a new non-rechargeable INS and Tined Lead. There were no complications noted with the procedure.

  Patient problems: Burning Sensation

  MAUDE report 50069735 ↗
• InjuryJul 14, 2026Migration

  It was reported that the patient with this Neurostimulator (INS) had surgery to revise their INS and Tined Lead. Additionally, the patient had this revision done was due to the INS falling out of their pocket. The patient stated their INS felt too superficial. The patient received a new INS and Tined Lead. There was no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815450 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THE NEUROSTIMULATOR HAD THEIR DEVICE EXPLANTED BECAUSE THEY WERE NOT GETTING SYMPTOM RELIEF AND SHE WAS HAVING SORENESS AT THE BATTERY SITE.

  Patient problems: Discomfort

  MAUDE report 25680067 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH THE SACRAL NEUROMODULATION SYSTEM WAS NOT RESPONDING TO THE THERAPY, AND REQUESTED TO HAVE THEIR DEVICE REMOVED, SO THEY COULD GO WITH BOTOX OPTION INSTEAD. THE PATIENT HAD THEIR DEVICE REMOVED ON (B)(6) 2026. THERE WERE NO OTHER ISSUES OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602280 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A RECHARGEABLE SNM IPG BEGAN EXPERIENCING STIMULATION DOWN THEIR LEG WHEN INCREASING THE STIMULATION. THE PATIENT NOTICED THIS BEGAN AFTER THEIR CHILD JUMPED ON THEIR LOWER BACK. THE PATIENT UNDERWENT AN X-RAY WITH NO ISSUES NOTED. THE LEAD WAS REPLACED TO THE CONTRALATERAL SIDE ON THE RIGHT WHILE THE INS REMAINED IN THE INITIAL POCKET ON THE LEFT SIDE OF THE PATIENT'S BODY. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE REPLACEMENT PROCEDURE.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25555728 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IMPLANTED WITH THIS NEUROSTIMULATOR (INS) WANTS IT REMOVED BECAUSE THEY DO NOT USE IT ANYMORE. ADDITIONALLY, THE PATIENT WAS HAVING INCONSISTENT RESULTS. THEY HAD TESTING DONE WITH THEIR UROLOGIST AND PRIMARY CARE PROVIDER AND DISCOVERED THEY HAD SOME CHANGES IN THEIR DIAGNOSIS AND NEW HEALTH ISSUES. THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT STATED ALL WENT WELL. THEY HAD IT REMOVED DUE TO A NEW DIAGNOSIS AND HEALTH ISSUES THAT ARE UNRELATED TO THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25356313 ↗
• InjuryMay 28, 2026Lack of Effect

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) CONTACTED THE CLINIC EXPRESSING FRUSTRATION WITH THE NEED FOR FREQUENT CHARGING AND LACK OF THERAPEUTIC IMPROVEMENT. THE PATIENT REPORTED THAT THERAPY HAD NOT PROVIDED SUSTAINED BENEFIT DESPITE MULTIPLE PROGRAMMING ADJUSTMENTS. AT THE TIME OF EVALUATION, THE PATIENT WAS ON PROGRAM P1L2 AND REPORTED PERCEIVING STIMULATION BILATERALLY. THE PATIENT REPORTED THAT AVAILABLE PROGRAMS DID NOT PROVIDE SYMPTOM RELIEF. DUE TO CONTINUED LACK OF PERCEIVED BENEFIT, THE PATIENT UNDERWENT DEVICE EXPLANTATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319794 ↗
• InjuryMay 22, 2026Lack of Effect

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED UNDESIRED SENSATIONS IN THE LEG, ALONG WITH LACK OF THERAPEUTIC BENEFIT AND DISCOMFORT. THE PATIENT UNDERWENT DEVICE EXPLANTATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 25261895 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR (INS) HAD SURGERY TO SWAP THEIR RECHARGEABLE INS FOR A NON-RECHARGE VERSION. THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233447 ↗
• InjuryApr 9, 2026Charging Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR BEGAN TO EXPERIENCE CHARGING ISSUES, AS THE PATIENT'S BASELINE SYMPTOMS WERE RETURNING. IT WAS NOTED THE REMOTE WOULD NOT CONNECT AS THE DEVICE WAS GOING INTO HIBERNATION MODE. THE CHARGER WAS PUT OVER THE INS TO REMOVE FROM HIBERNATION MODE. THE CHARGER CONNECTED TO THE INS AND THE PATIENT WAS ABLE TO CHARGE. IT WAS CONFIRMED THE IMPEDANCES WERE GOOD; HOWEVER, THE BATTERY WAS LOW. THE PATIENT CHARGED THE INS THAT NIGHT AND THE FOLLOWING MORNING FOR ONE HOUR AND IT WAS CONFIRMED THE BATTERY WAS SOLID GREEN. THE REMOTE FAILED TO CONNECT AFTER FOUR ATTEMPTS AND AFTER RESETTING THE REMOTE, THE CONNECTION WAS STILL UNSUCCESSFUL. A DIFFERENT CHARGER WAS USED FOR 30 MINUTES BEFORE RECEIVING THE DISCONNECT TONE AND WHEN ATTEMPTING TO CONNECT THE PATIENT'S REMOTE IT FLASHED WITH AN ORANGE LIGHT BEFORE TURNING OFF. THE PATIENT MET WITH THE PHYSICIAN TO TROUBLESHOOT AND DISCUSS INS REVISION. IT WAS NOTED THAT IMPEDANCES REMAIN GOOD AND THE BATTERY WAS COMPLETELY DEPLETED. THE INS WENT BACK INTO HIBERNATION MODE. THE PATIENT'S INS WAS REVISED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831802 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT TURNED OFF THEIR DEVICE DUE TO PAIN. THE PATIENT STATED THEY HAVE CHRONIC CYSTITIS AND MAKES THEM FREQUENTLY URINATE. THE PATIENT ALSO HAD FREQUENT URINARY TRACT INFECTIONS AND PAIN IN THEIR RECTUM. THE PHYSICIAN HAD THE PATIENT TURN OFF THEIR STIMULATION AND THE PATIENT SAID THE PAIN SUBSIDED BUT STILL PRESENT. ADDITIONALLY, THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD ON (B)(6) 2026. THE PHYSICIAN RECOMMENDED THE REMOVAL DUE TO THE DISCOMFORT. PER THE PATIENT, THEY ARE DOING BETTER NOW AND THERE IS NO MORE PAIN AROUND THE SITE.

  Patient problems: Discomfort; Pain; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 24693985 ↗
• InjuryMar 11, 2026Migration

  IT WAS REPORTED THAT A PATIENT HAD AN UNKNOWN DATE OF LEAD MIGRATION AND DECREASED EFFICACY OF THERAPY, AND NO KNOWN INJURY OR TRAUMA. THE PATIENT CONTACTED THEIR PHYSICIAN'S OFFICE IN LATE (B)(6) 2025, UNSURE OF THE EXACT DATE, AND HAD X-RAYS DONE OF THEIR DEVICE PLACEMENT. THE IMAGES CONFIRMED THERE WAS LEAD MIGRATION, AND THE PATIENT WAS OFFERED TO CONTACT THEIR REPRESENTATIVE FOR POSSIBLE REPROGRAMMING OR TO SCHEDULE A REVISION PROCEDURE. THE PATIENT DECLINED BOTH OPTIONS AT THAT TIME AND WANTED TO THINK ABOUT THEIR OPTIONS, AND THE REPRESENTATIVE WAS NOT CONTACTED AT THIS TIME OF THE EVENT. THE PATIENT THEN CALLED THEIR OFFICE AGAIN ON (B)(6) 2026 WITH INCREASED DISCOMFORT AT THE INS SITE AND A CONTINUED DECREASE IN EFFICACY AND WANTED TO MOVE FORWARD WITH THE REVISION PROCEDURE. THE REPRESENTATIVE WAS NOTIFIED ON (B)(6) 2026, AND THE PATIENT IS SCHEDULED FOR THEIR REVISION ON (B)(6) 2026. THE PATIENT HAD A FULL DEVICE REVISION OF BOTH INS AND LEAD ON (B)(6) 2026 AS SCHEDULED. THERE ARE NO OTHER ISSUES OR COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain; Urinary Incontinence

  MAUDE report 24574305 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD SURGERY TO EXPLANT THEIR NEUROSTIMULATOR AND TINED LEAD. THE PATIENT NOTIFIED THEIR LOCAL CARE TEAM THAT THEY HAD IT REMOVED. THE PATIENT DID NOT GIVE ANY FURTHER INFORMATION AS TO WHEN IT HAPPENED OR WHAT HAPPENED TO THEIR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573307 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NO LONGER HAS THEIR AXONICS SYSTEM. THE PATIENT STATED IT DID NOT WORK FOR THEM. THERE WERE NO OTHER ISSUES OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514535 ↗
• InjuryMar 2, 2026Charging Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING DIFFICULTIES WITH CHARGING. THE PATIENT WANTED A NON-RECHARGEABLE DEVICE. THE PATIENT NOTED THAT THE STIMULATION WAS WORKING, BUT WAS INCONSISTENT, AND BELIEVED THAT IT WAS DUE TO THE CHARGING ISSUES. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483508 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD THEIR DEVICE REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE. THERE WERE NO CLINICAL COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298254 ↗
• MalfunctionFeb 2, 2026Charging Problem

  IT WAS REPORTED THE PATIENT HAD SURGERY TO REVISE THEIR NEUROSTIMULATOR. INITIALLY, THE PATIENT HAD DIFFICULTY WITH KEEPING THEIR IMPLANT CHARGED. THE PATIENT WAS EDUCATED ON CHARGING STEPS, BUT THE PATIENT MOVED FORWARD WITH SWAPPING THEIR NEUROSTIMULATOR FOR A NON-RECHARGE VERSION. THE PATIENT IS DOING GREAT. THEY HAVE NOT HAD ANY EPISODES OF INCONTINENCE SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242800 ↗