Axonics 1701Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10810005340134), received between Feb 1, 2020 and Sep 29, 2026 — classified as 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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 31 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941057 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941036 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941021 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941020 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941019 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940888 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940678 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940542 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940537 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940536 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940194 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940189 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50940066 ↗
• InjuryApr 22, 2026Fracture; Unexpected Therapeutic Results; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF LEAD BREAKAGE/FRACTURE, IN ALL CASES AT THE IDENTICAL SIDE OF THE LEAD, DIRECTLY LOCATED AT THE TRANSITION FROM THE RIGID SECTION TO ITS FLEXIBLE SECTION. THESE ALL OCCURRED DURING TRIAL STAGES AFTER THE LEAD HAD BEEN PLACED IN THE PATIENT. IN MOST CASES, THE FRACTURE RESULTED IN LOSS OF ISOLATION AND EXPOSURE OF THE CABLE CORE/STRAND WITH SHORT CIRCUIT, LOSS OF CONNECTIVITY TO THE PATIENT'S REMOTE, LOSS OF DEVICE FUNCTION, AND TERMINATION OF THE TESTING PHASE DUE TO THE REMOVAL OF THE LEAD. THE PHYSICIAN IS HAVING TO CONSIDER SWITCHING BACK TO THE PREVIOUS TRIAL DEVICE THEY'VE USED FOR THE TIME BEING BECAUSE OF THE ISSUE THAT OCCURRED IN THE MOST RECENT 6 CASES UNTIL THE ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960420 ↗
• InjuryApr 22, 2026Fracture; Unexpected Therapeutic Results; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF LEAD BREAKAGE/FRACTURE, IN ALL CASES AT THE IDENTICAL SIDE OF THE LEAD, DIRECTLY LOCATED AT THE TRANSITION FROM THE RIGID SECTION TO ITS FLEXIBLE SECTION. THESE ALL OCCURRED DURING TRIAL STAGES AFTER THE LEAD HAD BEEN PLACED IN THE PATIENT. IN MOST CASES, THE FRACTURE RESULTED IN LOSS OF ISOLATION AND EXPOSURE OF THE CABLE CORE/STRAND WITH SHORT CIRCUIT, LOSS OF CONNECTIVITY TO THE PATIENT'S REMOTE, LOSS OF DEVICE FUNCTION, AND TERMINATION OF THE TESTING PHASE DUE TO THE REMOVAL OF THE LEAD. THE PHYSICIAN IS HAVING TO CONSIDER SWITCHING BACK TO THE PREVIOUS TRIAL DEVICE THEY'VE USED FOR THE TIME BEING BECAUSE OF THE ISSUE THAT OCCURRED IN THE MOST RECENT 6 CASES UNTIL THE ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958599 ↗
• InjuryApr 22, 2026Fracture; Unexpected Therapeutic Results; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WERE 6 CASES OF LEAD BREAKAGE/FRACTURE, IN ALL CASES AT THE IDENTICAL SIDE OF THE LEAD, DIRECTLY LOCATED AT THE TRANSITION FROM THE RIGID SECTION TO ITS FLEXIBLE SECTION. THESE ALL OCCURRED DURING TRIAL STAGES AFTER THE LEAD HAD BEEN PLACED IN THE PATIENT. IN MOST CASES, THE FRACTURE RESULTED IN LOSS OF ISOLATION AND EXPOSURE OF THE CABLE CORE/STRAND WITH SHORT CIRCUIT, LOSS OF CONNECTIVITY TO THE PATIENT'S REMOTE, LOSS OF DEVICE FUNCTION, AND TERMINATION OF THE TESTING PHASE DUE TO THE REMOVAL OF THE LEAD. THE PHYSICIAN IS HAVING TO CONSIDER SWITCHING BACK TO THE PREVIOUS TRIAL DEVICE THEY'VE USED FOR THE TIME BEING BECAUSE OF THE ISSUE THAT OCCURRED IN THE MOST RECENT 6 CASES UNTIL THE ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958586 ↗
• InjuryDec 30, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT HAD A BILATERAL PNE PROCEDURE, AND DURING RECOVERY THE PATIENT WAS UNABLE TO FEEL STIMULATION ON BOTH LEADS. THE PHYSICIAN ORDERED AN X-RAY, WHICH SHOWED THE LEADS HAD COME OUT OF THE FORAMEN AND WERE SITTING IN THEIR SUBCUTANEOUS TISSUE. IT WAS ASSUMED BY THE PHYSICIAN THAT THE LEADS HAD MIGRATED WHEN THE PATIENT WAS BEING TRANSFERRED. THE PATIENT IS SCHEDULED FOR A STAGE 1 PROCEDURE, AND THE PHYSICIAN HAS ELECTED TO GO WITH MEDTRONIC PRODUCT FOR THE PATIENT. THERE WERE NO OTHER ISSUES OR COMPLICATIONS REPORTED.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923592 ↗
• InjuryDec 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS NEUROSTIMULATOR GOING THROUGH A TRIAL STAGE WAS ADMITTED TO THE HOSPITAL FOR A WORKUP OF INTERNAL BLEEDING. THE PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY. THE PATIENT WAS PROGRAMMED POST-OPERATIVELY WITH FEELING STIMULATION IN THE PROPER AREA ON BOTH PROGRAMS, AND NO CONCERNS OR ABNORMALITIES WERE NOTED AT THAT TIME. FOLLOW-UP CALLS WERE MADE DAILY AFTER THE PROCEDURE, AND THE PATIENT REPORTED IMPROVEMENTS IN THEIR BOWEL AND BLADDER SYMPTOMS, CONTINUATION OF COMFORTABLE STIMULATION WITH NO ISSUES, CONCERNS, OR COMPLAINTS. ON (B)(6) 2025, THE PATIENT CALLED REQUESTING HELP TO INCREASE THEIR STIMULATION AS THEY WERE NOT FEELING IT, AND THE ADJUSTMENT WAS MADE TO INCREASE THE STIMULATION. THERE WERE NO COMPLAINTS OR DISCOMFORT AT THE TIME. THE PATIENT CALLED BACK LATER IN THE DAY, COMPLAINING OF UNCOMFORTABLE PRESSURE IN THEIR RECTUM. STIMULATION WAS DECREASED UNTIL THEY WERE COMFORTABLE BUT DID HAVE TROUBLE CONNECTING THEIR REMOTE TO THEIR EXTERNAL TRIAL STIMULATOR AT THE TIME OF THE CALL. THE PATIENT CALLED BACK AGAIN AND EXPRESSED CONCERN ABOUT STILL HAVING DISCOMFORT, SO THEY DECIDED TO TURN OFF THE STIMULATION AND THEN RE-EVALUATE WITHIN A

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Inappropriate Device Stimulation of Tissue; Pain; Perforation; Undesired Nerve Stimulation

  MAUDE report 23705396 ↗
• InjuryNov 10, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THE PATIENT CANCELLED THE PERMANENT IMPLANT PROCEDURE DUE TO LEG PAIN OCCURRING AFTER THE PNE LEADS WERE PULLED. THE PATIENT HAD THEIR GABAPENTIN DOSAGE INCREASED AND WAS PRESCRIBED A FIVE-DAY COURSE OF STEROIDS, THOUGH THE PATIENT WAS STILL EXPERIENCING SOME PAIN. THE PATIENT SAID THE PAIN WAS FELT IN BOTH LEGS. THE PATIENT SAW THEIR PRIMARY CARE PROVIDER AND BELIEVED IT WAS TRIGGERED BY THE STIMULATION OF THEIR NERVE.

  Patient problems: Discomfort; Pain

  MAUDE report 23512857 ↗
• InjuryAug 25, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WENT IN FOR A STANDARD PNE PROCEDURE. DURING THE PROCEDURE, STIMULATION WAS DELIVERED BUT NO SENSATIONS WERE FELT, EVEN AT HIGHER AMPLITUDES. ADJUSTMENTS WERE MADE, BUT LITTLE STIMULATION WAS FELT AND THE PATIENT BEGAN TO FEEL UNCOMFORTABLE. SATISFACTORY TEST STIMULATION WAS NOT ACHIEVED, SO THE PATIENT GREW MORE UNCOMFORTABLE AND DECIDED TO ABORT THE PROCEDURE. THE PATIENT REPORTED TO THE EMERGENCY ROOM AND COMPLAINED OF PAIN AND POSSIBLE PARALYSIS. THE TRUE DIAGNOSIS WAS UNKNOWN AS THE PATIENT WOULD NOT SHARE MEDICAL INFORMATION REGARDING THEIR EMERGENCY ROOM VISIT. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain; Paralysis

  MAUDE report 22884892 ↗
• InjuryJun 4, 2024Break; Break

  SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

  Patient problems: Incontinence

  MAUDE report 19464098 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PHYSICIAN DISCOVERED AN INFECTION AT THE LEAD SITE RESULTING FROM THE BASIC TRIAL.

  Patient problems: Cellulitis

  MAUDE report 13003041 ↗
• MalfunctionDec 9, 2020Low impedance; Low impedance

  THE COMPANY WAS MADE AWARE ON (B)(6) 2020 OF A PNE LEAD THAT SHOWED LOW IMPEDANCE. THE LEAD WAS EXPLANTED AND A REPLACEMENT IS PLANNED, BUT HAS YET TO BE SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 10979381 ↗
• MalfunctionJun 5, 2020Impedance Problem; Impedance Problem

  PNE LEAD IMPEDANCES WERE ALL GREEN UNTIL PATIENT WAS DRESSED. ONCE PATIENT WAS DRESSED, LEAD NUMBER 2 AND GROUND PAD SHOWED RED IMPEDANCES. DRESSING WAS REMOVED AND IMPEDANCES BECAME INTERMITTENTLY GREEN AND RED. THE GROUND PAD WAS REMOVED AND THE IMPEDANCES ON BOTH LEAD NUMBER 1 AND 2 WERE GREEN. PATIENT WAS PROGRAMMED SUCCESSFULLY WITH NO GROUND PAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10123473 ↗
• MalfunctionMay 8, 2020Impedance Problem; Impedance Problem

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES AND SECTION H, NUMBER 10, ADDITIONAL MANUFACTURER NARRATIVE.

  Patient problems: Failure of Implant; Therapeutic Response, Decreased

  MAUDE report 10039477 ↗