Axonics 1201Recalls & reported problems

Summary

The FDA's MAUDE database contains 481 adverse event reports that list this exact device (DI 10810005340141), received between Feb 13, 2020 and Sep 29, 2026 — classified as 341 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Migration” (191 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 481 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941141 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with the neurostimulator underwent an explant due to inadequate stimulation of the lead.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50937699 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 50698736 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 50698224 ↗
• InjurySep 8, 2026Fracture

  It was reported that the patient with this Tined Lead had it fractured due to the patient fiddling with it. The physician said this patient is a twirler and fiddled with their Neurostimulator (INS) and twisted it so much that is caused the lead to fracture. The patient had surgery to revise their Tined Lead. The patient is doing well.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50674496 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an SNM Tined lead was experiencing a sharp sensation vaginally and pain at their implant site, regardless of the device being on or off. Troubleshooting was performed by field representatives through attempting multiple programs with different electrode configurations without success. The patient had their device explanted. No further information was provided.

  Patient problems: Implant Pain; Inappropriate Device Stimulation of Tissue

  MAUDE report 50616908 ↗
• InjurySep 4, 2026Communication or Transmission Problem; Impedance Problem

  It was reported that the patient with the neurostimulator is experiencing urinary incontinence and inadequate stimulation. The patient was met in the office and discovered a red light on their remote and an open impedance. The device was reprogrammed. The error message was cleared, and the patient underwent a lead revision on (b)(6) 2026.

  Patient problems: Inadequate Pain Relief; Urinary Incontinence

  MAUDE report 50609682 ↗
• InjurySep 4, 2026Migration

  Patient problems: Burning Sensation; Cramp(s) /Muscle Spasm(s); Pain; Urinary Incontinence

  MAUDE report 50600240 ↗
• InjurySep 4, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600108 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an advanced trial, the patient stated they had good symptom relief for 1-5 days first days of the trial. Then on (b)(6), 2026, the patient started feeling stimulation in the thigh area. Their bladder symptoms returned. The patient elected to revise their lead and add the neurostimulator the next day as they had symptom relief at the beginning of the trial. The surgery took place on (b)(6), 2026.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50568954 ↗
• InjuryAug 31, 2026Fracture; Communication or Transmission Problem; Impedance Problem

  It was reported that the patient with the neurostimulator presented with a red light displayed on their remote control during ongoing use. Device interrogation identified an initial connection error, which was cleared. Open impedances were observed on electrodes E1 and E2. Multiple impedance checks were performed with the patient in different positions, and the impedance status varied with positioning. Based on the troubleshooting results, a conductor wire fracture was suspected. No troubleshooting resolved the issue. The patient underwent a revision surgery for both the neurostimulator and tined lead on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533584 ↗
• InjuryAug 31, 2026High impedance; Communication or Transmission Problem

  It was reported that the patient with the neurostimulator (INS) had a red light on their remote. The patient denies any falls or trauma. The patient also reported loss of efficacy of device and worsening of symptoms. Troubleshooting occurred in the physician's office and upon connecting to the Clinician Programmer, there was an IPG error message "impedance out of range," open impedances. The device showed that it has been off for the last 30 days. X-rays have been ordered. The patient underwent lead revision.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 50531574 ↗
• InjuryAug 31, 2026High impedance

  It was reported that the patient with this Tined Lead had high impedance and caused ineffective treatment. Also, the patient was unable to feel stimulation at appropriate level on the one electrode that was not impeded. Troubleshooting attempts were made with reprogramming. Then the patient had surgery to revise their Tined Lead. There was no further patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515505 ↗
• InjuryAug 31, 2026Communication or Transmission Problem; Impedance Problem

  It was reported that a patient with a SNM Tined Lead contacted the representative after observing abnormal indicator lights on the remote control. The patient initially reported a solid red indicator light; however, during a subsequent discussion with the representative, both a solid red and green indicator light were reported. Troubleshooting was performed, including attempts to reprogram around electrode 2, which exhibited an open impedance. Reprogramming was unsuccessful. During follow up evaluation, the patient's remote again displayed a red indicator light, and open impedances were identified on three electrodes. Additional information received indicated that therapy was subsequently turned off, and the patient underwent system removal and replacement procedure. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515500 ↗
• InjuryAug 31, 2026High impedance; Communication or Transmission Problem; Material Twisted/Bent

  It was reported that a patient with a SNM Tined Lead experienced intermittent device shutoff and observed a red indicator light on the remote control. Troubleshooting was performed, during which open impedances were identified. Additional information received indicated that the lead was bent. The patient subsequently underwent a replacement procedure. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515473 ↗
• InjuryAug 25, 2026Impedance Problem

  It was reported that upon connecting the patient's neurostimulator (INS) to the clinician programmer, an error message appeared and open impedances were noted. The patient stated that their device was not functioning, but the patient later noted that they were fine with no pain or discomfort. The patient underwent an x-ray. A revision was performed and a new lead was placed successfully. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422514 ↗
• InjuryAug 12, 2026Fracture; High impedance

  It was reported that the patient had high impedance. They experienced no falls or trauma to their implant site. The patient had surgery to revise their Tined Lead and Neurostimulator (INS). During the revision, it was noted the lead was sheared off in the middle. The provider wanted to replace both the Tined Lead and INS. Additionally, after a one-week follow-up, the patient reported replacing a pad every time they use the bathroom due to some cognitive decline. The patient had their stimulation increased until they felt the sensation in the vaginal area. Another assessment and possible increase is scheduled in the next few weeks. There was no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223046 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem; Lack of Effect

  It was reported that a patient with a SNM Tined Lead experienced loss of therapeutic benefit. Multiple reprogramming attempts were performed; however, symptoms did not improve. The patient subsequently turned stimulation off and elected to undergo device explantation. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211001 ↗
• InjuryAug 6, 2026Fracture; Communication or Transmission Problem; Impedance Problem

  It was reported that the patient with this Implantable Neurostimulator (INS) had a red indicator light on the remote. Upon connection to the Clinician Programmer (CP), there was an error noted and only one electrode was functioning. The patient reported involvement in a severe vehicle accident approximately 18 months prior, after which symptoms had returned. It was noted that the lead was damaged with a suspected fracture from the accident. At the time, the patient had recovered from the accident and continued using the device on the remaining functional electrode for symptom relief. Additional information received indicated that the patient underwent system explant and replacement procedure. The patient was reported to be doing well and satisfied following the revision procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150612 ↗
• InjuryAug 4, 2026Fracture; Communication or Transmission Problem

  It was reported that the patient with this Implantable Neurostimulator (INS) experienced an increase in fecal incontinence. When attempting to increase stimulation, a red indicator light was observed on the remote. The INS was charged; however, the red indicator light persisted. Troubleshooting was performed over the phone, including switching between programs, without resolution, as a continuous red indicator light remained present on both programs. No recent falls were reported. An appointment was scheduled for further evaluation and in-person troubleshooting with the clinical specialist. Additional information received indicated that evaluation identified a fractured lead. The patient subsequently underwent explant and reimplant of the system. No further patient complications were reported.

  Patient problems: Fecal Incontinence

  MAUDE report 50135939 ↗
• InjuryAug 4, 2026Migration

  It was reported that the patient with this Neurostimulator (INS) experienced migration of the Tined Lead. The patient experienced pain and their lead was poking out of their insertion site. They turned off their stimulation and took an x-ray. There is an explant surgery scheduled. Additionally, the patient denied any trauma to their implant site, but they did report losing a significant amount of weight. The patient had surgery to explant their INS and Tined Lead. The local care team was not in attendance. There was no patient complications reported.

  Patient problems: Discomfort; Erosion; Pain; Weight Changes

  MAUDE report 50133405 ↗
• InjuryAug 4, 2026High impedance; Communication or Transmission Problem

  It was reported that the patient with an SNM Tined Lead had symptoms previously well-controlled that gradually got worse over 2-3 weeks. On checking their remote, the patient noticed a red error light, which could not be cleared over the phone. In clinic, the Clinician Programmer displayed 3 electrode open impedances and programming around the errors temporarily was performed, but patient symptoms did not improve. X-rays were taken with no issues found. The patient reported having no recent falls or trauma only bumped the back of their head lightly with no suspected damage. Patient underwent a successful full revision. They reported feeling well with bowel and bladder symptoms improved and no error codes. No other patient complications were reported as a result of this event.

  Patient problems: Micturition Urgency; No Clinical Signs, Symptoms or Conditions; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 50130183 ↗
• InjuryAug 3, 2026Migration

  It was reported that the patient with this Implantable Neurostimulator (INS) experienced a fall, after which the physician determined that the lead had migrated. The lead and INS were replaced with new devices. The patient was reported to be doing well, and no additional follow up was required. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122485 ↗
• InjuryJul 30, 2026Migration

  It was reported that the patient noted feeling pain and tenderness at their implant site. The patient underwent a lead revision and the lead was replaced.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50077964 ↗
• InjuryJul 2, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) UNDERWENT A LEAD REVISION DUE TO LOSS OF EFFICACY. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WITH INTUBATION. MULTIPLE ATTEMPTS WERE REQUIRED TO ESTABLISH THE AIRWAY, DURING WHICH BLEEDING AND FOAMING FROM THE MOUTH WERE OBSERVED, AND OXYGEN LEVELS DECREASED. ADDITIONAL SUPPORT WAS CALLED, AND THE PATIENT WAS SUBSEQUENTLY STABILIZED. THE PROCEDURE WAS THEN COMPLETED, AND THE PATIENT WAS REPORTED TO BE STABLE POST-OPERATIVELY. OVER THE WEEKEND FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A STROKE. THE HOSPITAL CONTACTED THE REPRESENTATIVE REQUESTING ASSISTANCE TO PLACE THE DEVICE IN MAGNETIC RESONANCE IMAGING (MRI) MODE FOR AN EMERGENCY MRI. THE REPRESENTATIVE WAS INFORMED OF AN EMERGENCY SITUATION AT THAT TIME. FOLLOW UP COMMUNICATION CONFIRMED THAT THE PATIENT HAD EXPERIENCED A STROKE AND DIED UNRELATED TO THE DEVICE OR THE PROCEDURE. THE DATE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE RELATIONSHIP OF THESE EVENTS TO THE DEVICE OR PROCEDURE AT THE TIME OF REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690770 ↗