Nalu Medical, Inc. 74001-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812537035444), received between Jun 27, 2022 and Sep 21, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 21, 2026Inappropriate/Inadequate Shock/Stimulation

  The Nalu Sales Representative (rep) reported that the patient said that he's having issues with his Therapy Disc (TD), that the Amplitude settings are changing and giving him shocks. No further information was provided. There was no reported patient harm or injury.

  Patient problems: Electric Shock

  MAUDE report 50839514 ↗
• InjuryMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2022 TARGETING THE CLUNEAL NERVE. ON (B)(6)2024 A NALU REPRESENTATIVE WAS MADE AWARE DURING A CONVERSATION WITH THE MEDICAL CLINIC THAT THE PATIENT HAD UNDERGONE A FULL SYSTEM EXPLANT ON (B)(6) 2024. PER THE CLINIC STAFF, THE PATIENT REQUESTED TO REMOVE THE SYSTEM DUE TO NON-USE. THE FIRM WAS NOT NOTIFIED PRIOR TO OR AT THE TIME OF THE SURGICAL INTERVENTION. THE FIRM BECAME AWARE OF THE INTERVENTION TWO DAYS LATER, ON (B)(6)2024. NO FIRM REPRESENTATIVES WERE PRESENT FOR THE EVENT AND THERE WAS NO OPORTUNITY FOR TROUBLESHOOTING OR INVESTIGATION PRIOR TO THE EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19245046 ↗
• InjuryJan 8, 2023Migration; Migration

  ON 22NOV2022 THE NALU QUALITY DEPARTMENT RESPONSIBLE FOR MDR REPORTING BECAME AWARE OF AN EXPLANT PROCEDURE THAT WAS PERFORMED ON (B)(6) 2022. AFTER THE INITIAL IMPLANT, THE DEVICE MIGRATED CAUSING CONNECTIVITY AND THERAPY DISRUPTION. A REVISION WAS PLANNED TO MOVE THE IPG TO A MORE OPTIMAL LOCATION FOR THE PATIENT'S ANATOMY. DURING THE PLANNED PROCEDURE ON (B)(6) 2022, THE PHYSICIAN INADVERTENTLY PULLED THE IMPLANTED LEADS AND IPG COMPLETELY OUT OF THE PATIENT. IN ORDER TO RE-IMPLANT THE PATIENT NEEDED TO BE AWAKE TO PROVIDE CONSENT. DUE TO TIME CONSTRAINTS, THE PROCEDURE WAS CONCLUDED WITH THE SYSTEM BEING FULLY EXPLANTED. A RE-IMPLANT WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2022 WITH NO REPORTS OF COMPLICATIONS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16119157 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PNS SYSTEM ON (B)(6) 2022. ON (B)(6) 2022 THE PATIENT PRESENTED WITH ONE IMPLANTED LEAD PARTIALLY PULLED OUT THROUGH THE SURGICAL INCISION. NALU REPRESENTATIVE WAS NOTIFIED ON (B)(6) 2022 OF THE SCHEDULED EXPLANT PROCEDURE THAT WAS PERFORMED ON (B)(6) 2022. THERE WAS NO FAILURE OF THE NALU SYSTEM AND THE PATIENT REPORTED DOING WELL WITH PAIN RELIEF PRIOR TO THE LEAD EXPOSURE.

  Patient problems: Impaired Healing

  MAUDE report 15380676 ↗
• InjuryJul 11, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  NALU WAS MADE AWARE OF A PLANNED REVISION ON (B)(6) 2022. ON (B)(6) 2021 THE PATIENT REPORTED THAT WHEN SITTING DOWN, THE NALU EXTERNAL TRANSMITTER MODULES (ETMS) WILL DISCONNECT AND START BEEPING. IT WAS NOTED THAT THE PATIENT'S SKIN IS VERY LOOSE AND THE EXTERNAL DISC MOVES EASILY ON THE SKIN WHEN THE PATIENT CHANGES POSITIONS. THE NALU REPRESENTATIVE ATTEMPTED MULTIPLE TROUBLESHOOTING STRATEGIES. ULTIMATELY THE PHYSICIAN AND PATIENT DECIDED TO REVISE THE IMPLANT TO A DIFFERENT STYLE THAT DOES NOT REQUIRE EXTERNAL COMPONENTS. NALU BECAME AWARE OF THIS DECISION ON (B)(6) 2022. NO OTHER INFORMATION IS AVAILABLE AS TO STATUS OR OUTCOME OF THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14982692 ↗
• InjuryJun 27, 2022Migration; Migration

  ON (B)(4) 2022 THE FIRM WAS MADE AWARE OF A REVISION PROCEDURE PREFORMED ON (B)(6) 2021. INITIAL COMMUNICATION FROM THE PATIENT AND DOCTOR ON (B)(6) 2021 INDICATED THAT THE EXTERNAL THERAPY DISC WAS NOT CONNECTING CONSISTENTLY TO THE IMPLANTED IPG COMPONENT. COMPANY REPRESENTATIVE ATTEMPTED MULTIPLE POSITIONS AND PRESSURES WITHOUT SUCCESS AND RECOMMENDED AN ULTRASOUND TO DETERMINE DEPTH AND POSITION OF THE IMPLANTED IPG. COMPANY FIELD REPRESENTATIVE REPORTED TO IT ON (B)(4) 2022 THAT A REVISION WAS PERFORMED ON (B)(6) 2021. THE UPDATE WAS RELAYED TO COMPANY QUALITY REPRESENTATIVES ON 27MAY2022. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837211 ↗