Axonics 4101Recalls & reported problems

Summary

The FDA's MAUDE database contains 801 adverse event reports that list this exact device (DI 10810005340455), received between Jun 29, 2022 and Sep 30, 2026 — classified as 1 death, 778 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Migration” (110 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 801 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fracture; High impedance; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951311 ↗
• InjurySep 30, 2026Migration

  Patient problems: Discomfort; Implant Pain; Micturition Urgency

  MAUDE report 50951302 ↗
• InjurySep 30, 2026Communication or Transmission Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950616 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 50941050 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with the neurostimulator underwent tined lead and INS revision due to pocket site pain and sensation in the leg. An x-ray was taken to see if the battery or lead have moved. Both the tined lead and the INS were revised from the left to the right. The tined lead was replaced and the INS was moved.

  Patient problems: Discomfort; Pain

  MAUDE report 50934074 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with the neurostimulator underwent a revision due to the device not working after an unrelated surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933966 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with this Neurostimulator had developed an infection on their right side near their implant pocket site. The patient had drainage at the implant site for several weeks. The physician removed the patient's implant battery and replaced it with a new recharge-free battery on the left side of the patient's body using a tyrex pouch that is absorbable with antibiotic. The physician kept the original lead in place. The procedure was completed and there were no additional patient complications reported.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50763346 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort

  MAUDE report 50600349 ↗
• InjurySep 4, 2026Migration

  Patient problems: Discomfort; Weight Changes

  MAUDE report 50600337 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50600332 ↗
• InjurySep 3, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600012 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599878 ↗
• InjurySep 3, 2026High impedance; Migration

  Patient problems: Incontinence

  MAUDE report 50599754 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fecal Incontinence

  MAUDE report 50599752 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burning Sensation

  MAUDE report 50599748 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Neurostimulator (INS) had surgery to revise their pocket on (b)(6) 2026. The same INS was used, but the pocket was moved due to excessive weight loss. There was no further patient complications reported.

  Patient problems: Weight Changes

  MAUDE report 50526948 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a Neurostimulator had a full system removal, due to lack of efficacy and symptom control for the patient. There were no additional patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526935 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with the neurostimulator (INS) is experiencing pain and discomfort at the pocket site. The patient underwent INS revision on (b)(6) 2026. The patient reports doing much better and the pain is no longer present and also reports an improvement in their symptoms as well.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 50515478 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with a Neurostimulator and an SNM Tined Lead was experiencing redness and itchiness in the implant site with "dots all over." Their doctor advised the patient was having a reaction to the suture used and should monitor for symptoms of infection. The patient went to the emergency room after noticing their incision had opened and the device was visible. This was caused by infection, and they were given antibiotics. The patient's doctor reached out to confirm the patient would have their implant removed due to wound dehiscence. The explant was successfully completed. There was no additional patient complications reported.

  Patient problems: Erythema; Itching Sensation; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 50515471 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Neurostimulator (INS) went to the emergency department due to pain. Upon examination, it was noted that the patient's INS had eroded through the skin. Then the patient had surgery to explant their INS and Tined Lead. There was no infection noted at the time, but they are waiting for the report on the intra-op swab. The patient was closed up and sent home. Additionally, per the physician, there was no infection present from the swab.

  Patient problems: Erosion; Pain

  MAUDE report 50515465 ↗
• InjuryAug 17, 2026Migration

  It was reported that the patient with this Neurostimulator (INS) experienced migration of the INS and sticking out against the skin. This was causing the patient pain. Per the physician, it was possibly due to the way the patient moved when they took their prosthetic leg on and off. The physician considered planting the INS deeper in the pocket. The local care team reached out to the Product Management team to consult on what the maximum depth of the INS placement should be and still able to communicate with the remote control. The patient was still getting great symptom improvement and did not want to lose their device. A pocket revision surgery was scheduled at a later date. Additionally, the local care team member confirmed the INS was not coming through the skin, breaking skin, nor coming through the incision. Later, the patient had surgery for a pocket revision. No complications occurred.

  Patient problems: Implant Pain

  MAUDE report 50287273 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with a Recharge-Free SNM IPG was experiencing pain and discomfort. An explant was done and replaced with a non-Boston Scientific device. No other patient complications were reported.

  Patient problems: Discomfort; Pain

  MAUDE report 50246796 ↗
• InjuryAug 11, 2026Migration

  It was reported that a patient with a Recharge-Free SNM IPG and SNM Tined Lead had a system revision after their symptom relief had decreased due to a fall. Lead migration was confirmed on X-ray. The patient also felt the device more superficial due to weight loss. The procedure was successful. The patient was content, having no fecal incontinence episodes and being able to void on their own. No other patient complications were reported as a result of this event.

  Patient problems: Weight Changes

  MAUDE report 50216516 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with a Recharge-Free SNM IPG was seen by the physician due to a suspected infection. The patient subsequently underwent system explanation. The patient tested positive for Methicillin resistant Staphylococcus aureus (MRSA) infection and was admitted for postoperative treatment. The patient was discharged. No further patient complications were reported.

  Patient problems: Bacterial Infection

  MAUDE report 50204421 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with this Neurostimulator was discharged from the hospital, and then developed a rash and redness around their incision site. The patient mentioned that their incision began to open (dehisced), resulting in an infection prior to their post op appointment. The physician removed the patient's device both implant battery and the lead, and placed the patient on antibiotics. There were no other issues or complaints mentioned at this time.

  Patient problems: Erythema; Rash; Unspecified Infection; Wound Dehiscence

  MAUDE report 50136176 ↗