Axonics 2201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10810005340158), received between Feb 28, 2020 and Mar 12, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2024Migration; Migration

  THE PATIENT UNDERWENT REVISION SURGERY DUE TO LEAD MIGRATION.

  Patient problems: Failure of Implant

  MAUDE report 18887139 ↗
• MalfunctionJun 18, 2020Migration; Migration

  PATIENT HAD A MASSAGE DONE. THE MASSAGE SESSION INCLUDED THE AREA OF THE IPG (NEUROSTIMULATOR) AND TINED LEAD INSERTION SITE. PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. X-RAYS WERE PERFORMED AND RESULTS SHOW THE LEAD HAD MIGRATED INWARD. THE PATIENT DECIDED TO HAVE THE SYSTEM EXPLANTED DUE TO RECOVERY TIME FOR A LEAD REVISION SURGERY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10171467 ↗
• MalfunctionJun 11, 2020Migration; Migration

  PATIENT'S LEAD MOVED AFTER THEIR FINAL IMPLANT. REVISION SURGERY NEEDED TO REPLACE THE LEAD.

  Patient problems: Failure of Implant

  MAUDE report 10146497 ↗
• MalfunctionMay 8, 2020Material Erosion; Material Erosion

  PATIENT UNDERWENT A RAPID WEIGHT LOSS PROGRAM WHERE THEY HAD LOST 38 POUNDS IN 2 MONTHS. THE DOCTOR STATED THE LEAD STRESS COIL AT THE IPG (NEUROSTIMULATOR) SITE HAD ERODED THROUGH THE SKIN. THE PATIENT WAS SCHEDULED FOR A FULL SYSTEM EXPLANT ON (B)(6) 2020.

  Patient problems: Erosion

  MAUDE report 10039444 ↗
• MalfunctionApr 8, 2020Failure to Read Input Signal; Impedance Problem; Failure to Read Input Signal; Impedance Problem

  WHEN THE LEAD STIMULATION CABLE WAS ATTACHED TO THE TINED LEAD, THE IMPEDANCE OF ALL 4 CONTACTS CAME UP AS OPEN IN RED AND THE CABLE WAS UNABLE TO READ THE THRESHOLDS FOR EACH CONTACT. THE NEEDLE TEST STIMULATION CABLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941486 ↗
• MalfunctionFeb 28, 2020Migration; Migration

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9772183 ↗