Axonics 9009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10810005340288), received between Sep 21, 2020 and Sep 4, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Trial Stimulator had an overnight hospital stay due to extreme pain. They received pain medication for it. The patient has unknown etiology back pain prior to the trial procedure and the procedure magnified the existing pain. When trying to determine where the pain was, the patient stated the pain was not where they felt the stimulation. The pain was near the pocket and wrapped around their back like a band. The patient did not explain how the pain felt. Additionally, the pain was controlled and the patient moved forward with the Stage 2 implant.

  Patient problems: Pain

  MAUDE report 50602217 ↗
• InjuryDec 26, 2025High impedance; Material Integrity Problem; High impedance; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE FOR THE EXTERNAL NEUROSTIMULATOR, THE TINED LEAD INITIALLY TESTED WITHIN RANGE, BUT REPEATED IMPEDANCE CHECKS SHOWED OPEN VALUES ON ALL ELECTRODES. MULTIPLE RECONNECTIONS AND IMPEDANCE TESTS WERE ATTEMPTED WITHOUT RESOLUTION. THE PHYSICIAN REOPENED THE INCISION, CONFIRMED INTACT LEAD INTEGRITY. THE PERCUTANEOUS EXTENSION WAS REPLACED AND ALL IMPEDANCES WERE TESTED WITHIN NORMAL LIMITS. THE CASE WAS COMPLETED USING THE REPLACEMENT EXTENSION. THE PATIENT HAD BEEN DOING WELL AND REPORTED BENEFITING FROM THE THERAPY. THIS EVENT OCCURRED DURING THE STAGE 1 TRIAL. NO FURTHER CLINICAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899171 ↗
• InjuryDec 9, 2024Migration; Migration

  THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION.

  Patient problems: Incontinence

  MAUDE report 20885879 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS MADE AWARE THAT A PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO MRSA INFECTION.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 15156993 ↗
• MalfunctionSep 21, 2020Disconnection; Disconnection

  ON (B)(6) 2020, CLINICAL SPECIALIST REPORTED THAT TRIAL LEADS HAD DISCONNECTED FROM THE PERCUTANEOUS EXTENSION WHILE HOME CARE NURSE WAS REMOVING THE DRESSINGS. THE PATIENT IS PARAPLEGIC. THE DISCONNECTION DAMAGED THE EXTENSION CABLE WHEN THE PATIENT WAS LIFTED ONTO THE HOYER LIFT. THE EXTENSION WAS REPLACED AND PATIENT IS DOING WELL.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10560925 ↗