Nalu Medical, Inc. 72003-US (UDI 00812537033631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00812537033631), received between Aug 26, 2021 and Sep 30, 2026 — classified as 2 deaths, 37 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Patient problems: Pain

  MAUDE report 50949994 ↗
• MalfunctionSep 30, 2026Fracture

  The Nalu Representative (rep) reported that the trial lead fractured upon removal. The physician left the electrode portion in and was not removed, as he is not sure whether it is the lateral or medial superior genicular lead that fractured. There was no reported patient harm or injury.

  Patient problems: Foreign Body In Patient

  MAUDE report 50948697 ↗
• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Skin Infection

  MAUDE report 50938642 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Skin Infection

  MAUDE report 50922510 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  The Nalu Representative (rep) reported that the patient reported an infection after lead pull and was prescribed antibiotics for 5 days.

  Patient problems: Skin Infection

  MAUDE report 50901693 ↗
• MalfunctionSep 24, 2026Break; Difficult to Remove

  Patient problems: Pain

  MAUDE report 50889269 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887177 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  The Nalu Representative (rep) reported that during the trial implantation, after the first lead was placed at the sciatic nerve, the patient did not feel paresthesia in the region of her pain. A second lead was placed at the common peroneal nerve, and the patient was discharged to the recovery room. At this time, the patient still did not achieve paresthesia in the region of her pain, and the plan was to attempt to achieve this with programming. Ultimately, the patient reported paresthesia in the region of her pain after programming, although she was reporting post-procedure pain at this time. The nurse dressed the area and provided thorough wound care instructions. At the time the patient was discharged, and it was our understanding that she was achieving paresthesia in the region of her pain. Two hours later, the patient reported severe pain that was affecting her ability to walk and was unwilling to return to the study site at that time because she was already an hour away. The patient felt at that time that her pain was attributed to the lead at the sciatic nerve. She was provided with instructions on removing the sciatic lead by the physician. After this conversation, there wa

  Patient problems: Pain

  MAUDE report 50872338 ↗
• InjuryJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6)2025 THE PATIENT WAS PREPPED AND ANESTHETIZED TO IMPLANT A NALU TRIAL SYSTEM. THE PERIPHERAL NERVE STIMULATOR TRIAL WAS INTENDED TO TREAT LOWER ARM PAIN BY TARGETTING THE BRACHIAL PLEXUS NERVE. DURING THE PROCEDURE, THE SPOONBILL NEEDLE THAT WAS PROVIDED BY NALU WAS INSERTED BUT THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEEDLE WITHOUT SIGNIFICANT PRESSURE DUE TO THE PATIENT'S THICK TISSUE AND VASCULAR STRUCTURES IN THE AREA OF INSERTIONS. AFTER UNSUCCESSFUL ATTEMPTS TO ADVANCE THE SPOONBILL NEEDLE, THE PHYSICIAN REPORTED BEING UNCOMFORTABLE PROCEEDING AND THE PROCEDURE WAS ABORTED. THE PHYSICIAN NOTED THAT THERE WAS NO OTHER APPROACH HE WAS COMFORTABLE WITH DUE TO THE PATIENT'S ANATOMY AND THE DESIRED NERVE TARGET. THE PATIENT WAS DISCHARGED WITH NO ADVERSE REACTIONS AFTER THE UNSUCCESSFUL TRIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157956 ↗
• InjurySep 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT BEGAN A TRIAL WITH NALU'S PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. ON (B)(6) 2024 THE TRIAL SYSTEM WAS REMOVED AS PLANNED, HOWEVER THE PATIENT LATER REPORTED PAIN AT THE INCISION AREA AND PRESENTED TO THE LOCAL ACUTE FACILITY FOR EVALUATION. PER THE IMPLANTING PHYSICIAN, THE PATIENT WAS BELIEVED TO HAVE AN INFECTION AND WAS TREATED BY THE FACILITY, INCLUDING CLEANING THE INCISION SITE. NO FURTHER DETAILS WERE SHARED WITH THE FIRM. IT IS UNCLEAR WHAT THE TREATMENT WAS OR IF THE PATIENT WAS ADMITTED TO THE FACILITY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20276191 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM ON (B)(6) 2024. THROUGHOUT THE TRIAL THE PATIENT NOTED OCCASIONAL SPOTTING OF BLOOD/DISCHARGE ON THE SURGICAL DRESSING AT THE LEAD INSERTION SITE. PATIENT DECLINED DRESSING CHANGES WHILE THE TRIAL SYSTEM WAS IN PLACE. ON (B)(6) 2024 THE TRIAL SYSTEM WAS REMOVED AS PLANNED. ON 06/28/2024 THE FIRM WAS NOTIFIED THAT THE PATIENT HAD BEEN HOSPITALIZED ON (B)(6) 2024 FOR A BLOOD INFECTION. THROUGHOUT THE TRIAL PROCESS, THE PATIENT REPORTED NO SWELLING, DRAINAGE, ODOR, TEMPERATURE CHANGE, OR OTHER SIGNS OF INFECTION AT THE INSERTION SITE. ONE WEEK AFTER THE TRIAL ENDED AND LEADS WERE REMOVED AS PLANNED, THE PATIENT WAS ADMITTED TO THE HOSPITAL. AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT SHARED WITH A FIRM REPRESENTATIVE THAT THEY WERE TAKING ORAL ANTIBIOTICS DURING THE NALU TRIAL FOR A DENTAL ABSCESS. THE PRESENCE OF THE ABSCESS AND ANTIBIOTICS WERE NOT SHARED WITH THE FIRM UNTIL A FULL WEEK AFTER THE TRIAL ENDED.

  Patient problems: Unspecified Infection

  MAUDE report 19826605 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR TRIAL SYSTEM ON (B)(6) 2024. WHEN THE PATIENT ARRIVED TO THE MEDICAL CLINIC ON (B)(6) 2024 TO REMOVE THE TRIAL SYSTEM AS PLANNED, THE PATIENT REPORTED COMPLAINTS OF PAIN AT THE LEAD ENTRY SITE. PATIENT ALSO REPORTED VOMITING AND DIZZINESS THE PREVIOUS NIGHT. VISUAL VERIFICATION FOUND DISCHARGE AT THE INSERTION SITE. TRIAL SYSTEM LEADS WERE REMOVED AS PLANNED, THE PHYSICIAN CLEANED AND DRESSED THE INSERTION SITE AND REFERRED THE PATIENT TO A LOCAL EMERGENCY DEPARTMENT FOR EVALUATION OF THE SITE. UPON EVALUATION, THE PATIENT WAS ADMITTED TO THE ACUTE FACILITY FOR TREATMENT OF INFECTION AT THE INSERTION SITE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19672803 ↗
• InjuryMay 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 AN 88 YEAR OLD FEMALE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR TRIAL SYSTEM.THE TEMPORARY TRIAL LEADS WERE PLACED AT T8-T9 AREA TO TARGET LOWER BACK PAIN. THE PROCEDURE LASTED APPROXIMATELY 20 MINUTES. WHILE THE PATIENT WAS ON THE TABLE BEING BANDAGED, SHE COMPLAINED OF DISCOMFORT IN THE NECK AREA. PATIENT WAS ASSISTED TO A SITTING POSITION FOR THE PHYSICIAN TO FINISH THE BANDAGING PROCESS. UPON STANDING, THE PATIENT REPORTED SOME WEAKNESS IN THE LOWER EXTREMITIES. THE TRIAL SYSTEM WAS ACTIVATED DURING POST-OP PROCEDURES, HOWEVER THE STIMULATION WAS RUN AT VERY LOW SETTINGS TO ALLOW THE PATIENT TO RECOVER FROM THE PROCEDURE AND BECOME ACCUSTOMED TO THE THERAPY. PATIENT'S DAUGHTER WAS PRESENT TO TAKE THE PATIENT HOME AND STAYED WITH HER THROUGHOUT THE SUBSEQUENT SEVERAL DAYS. ON (B)(6) 2024 THE PATIENT CONTACTED THE PHYSICIAN TO REPORT ONGOING DISCOMFORT/WEAKNESS IN THE LOWER EXTREMITIES. PATIENT WAS SEEN IN THE PHYSICIAN'S OFFICE AND THE PHYSICIAN ATTRIBUTED THE SYMPTOMS REPORTED TO NORMAL POST-OP DISCOMFORT. DURING THE NIGHT ON (B)(6) 2024 THE PATIENT REPORTEDLY GOT OUT OF BED AT SOME TIME DURING THE NIGHT AND SUSTAINED A FALL IN WHICH SHE STRUCK HER

  Patient problems: Loss of consciousness

  MAUDE report 19348750 ↗
• InjuryMar 28, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM ON (B)(6) 2024 TO TREAT SHOULDER PAIN. DURING USE OF THE TRIAL SYSTEM THE PATIENT COMMUNICATED THE DESIRE TO REMOVE THE BANDAGES FROM THE INSERTION SITE AND WAS INSTRUCTED TO LEAVE THE BANDAGES INTACT AND NOT REMOVE. WHEN THE PATIENT ARRIVED TO THE CLINIC TO REMOVE THE TRIAL SYSTEM, THE BANDAGES WERE REMOVED AND THE TRIAL LEADS WERE NOT PRESENT OR NOT VISIBLE AT THE INSERTION SITE. PATIENT REPORTED THAT THE LEADS MAY HAVE "COME LOOSE" AND ADMITTED TO REMOVING THE BANDAGES AT HOME. CONFIRMED THAT ONE OF THE TRIAL LEADS WAS IN THE BANDAGE, HOWEVER THE SECOND LEAD WAS UNABLE TO BE VISUALLY LOCATED. PATIENT AND WIFE STATED THAT DURING BANDAGE REMOVAL AT HOME THEY HAD CUT SOMETHING BUT WERE UNSURE WHAT HAD BEEN CUT. XRAY IMAGING CONFIRMED THAT A PIECE OF ONE OF THE TRIAL LEADS HAD BEEN CUT OFF AND REMAINED IN THE PATIENT'S SHOULDER. AN ADDITIONAL, UNANTICIPATED PROCEDURE WAS PERFORMED ON 29FEB2024 TO REMOVE THE REMAINING TRIAL LEAD FROM THE PATIENT'S SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19001312 ↗
• InjuryJan 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM ON (B)(6) 2023 AND HAD THE SYSTEM REMOVED AS PLANNED ON (B)(6) 2023. ON 28DEC2023 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS AT AN ACUTE INPATIENT FACILITY FOR IV ANTIBIOTICS FOR AN INFECTION. THE PATIENT REPORTED TO THE FIRM THAT THEY BELIEVE THE INFECTION WAS RELATED TO THE TRIAL PROCESS. THERE WERE NO SIGNS OF INFECTION NOTED AT THE TIME OF LEAD PULL AND THERE ARE NO LAB CULTURE RESULTS AVAILABLE TO THE FIRM TO CONFIRM THE TYPE OR LOCATION OF THE INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18592781 ↗
• InjuryDec 29, 2023Failure to Advance; Failure to Advance

  ON (B)(6) 2023 A SURGICAL PROCEDURE WAS ATTEMPTED AND ABORTED. PATIENT WAS SCHEDULED TO RECEIVE THE NALU SPINAL CORD STIMULATOR TRIAL SYSTEM IMPLANTED, HOWEVER UPON ATTEMPTING TO INSERT THE LEADS THE PHYSICIAN FOUND HE WAS UNABLE TO INSERT THE LEADS PAST THE T10 VERTEBRA. PHYSICIAN ATTEMPTED ENTRY AT L1/2 AND MOVED UP TO T12/L1 ALSO WITH NO SUCCESS. PHYSICIAN INJECTED CONTRAST DYE INTO THE EPIDURAL SPACE AND WAS NOT ABLE TO ACHIEVE ANY FLOW UPWARD OR LATERALLY. ULTIMATELY THE PHYSICIAN ELECTED TO ABORT THE PROCEDURE WITHOUT PLACING THE SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18416537 ↗
• DeathNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 THE PATIENT WAS PREPPED FOR IMPLANT OF A NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM, TARGETING THE CLUNEAL NERVE TO TREAT LOWER BACK PAIN. PATIENT WAS ADMINISTERED ANESTHESIA FOR THE PROCEDURE AND PLACED IN A PRONE POSITION. THE PHYSICIAN IMPLANTED THE TRIAL LEADS AT THE DESIRED POSITION. THE PROCEDURE LASTED APPROXIMATELY 10 MINUTES. AFTER IMPLANTING THE TRIAL LEADS, THE ATTENDING CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) ATTEMPTED TO REVIVE THE PATIENT AFTER THE PROCEDURE AND DISCOVERED THE PATIENT HAD GONE INTO CARDIAC ARREST. CHEST COMPRESSIONS WERE INITIATED. EMERGENCY MEDICAL SERVICES ARRIVED SEVERAL MINUTES LATER AND CONTINUED CPR. THE PATIENT WAS UNABLE TO BE REVIVED AND WAS EVENTUALLY PRONOUNCED DEAD.

  Patient problems: Cardiac Arrest

  MAUDE report 18046309 ↗
• InjuryOct 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT BEGAN THE TRIAL PHASE FOR THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6)2023. AFTER IMPLANTING THE TRIAL LEADS THE PATIENT WAS UNABLE TO GET ANY NEURAL RESPONSE FROM THE SYSTEM. THE INTENTION WAS TO TARGET THE SUPRASCAPULAR NERVE, HOWEVER IT WAS SUSPECTED THAT THE LEADS WERE FLOATING ABOVE THE SUPRASCAPULAR FOSSA INSTEAD OF HITTING THE DESIRED LOCATION. A SURGICAL REVISION WAS PERFORMED ON (B)(6)2023 TO REMOVE THE IMPLANTED TRIAL LEADS AND REPLACE WITH A NEW SET OF LEADS TARGETTING THE DESIRED NERVE LOCATION. THE TRIAL WAS COMPLETED SUCCESSFULLY AND THE LEADS WERE REMOVED AS PLANNED ON (B)(6)2023. PATIENT IS PREPARING FOR PERMANENT IMPLANT PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17917438 ↗
• InjuryAug 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR TRIAL SYSTEM TO TREAT RIGHT SIDED LOWER BACK AND UPPER LEG PAIN. PROCEDURE WAS NORMAL WITH NO COMPLICATIONS REPORTED AND ALL INTRA-OP TESTING SATISFACTORY. PATIENT WAS MOVED TO THE POST-ANESTHESIA CARE UNIT FOR RECOVERY FROM THE PROCEDURE AND TO BEGIN PROGRAMMING THE SYSTEM. PRIOR TO BEGINNING PROGRAMMING, THE PATIENT REPORTED EXCESSIVE PAIN IN THE LEFT FOOT AND LEG. PATIENT WAS UNABLE TO BE CONSOLED WITH ANY TREATMENT OR PLAN OF CARE IN THE RECOVERY UNIT. PHYSICIAN DECIDED TO COMPLETELY REMOVE THE TRIAL LEADS IMMEDIATELY. AFTER EXPLANT, THE PATIENT REPORTED HAVING PAIN LEVELS AT A LEVEL WHERE THEY WERE COMFORTABLE TO LEAVE THE FACILITY AND FOLLOW UP WITH THE PHYSICIAN IN THE CLINIC THE FOLLOWING DAY.

  Patient problems: Pain

  MAUDE report 17581175 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE TRIAL SYSTEM ON (B)(6) 2023. DURING THE TRIAL THE PATIENT REPORTED NOT GETTING PAIN RELIEF TO THE TARGETED AREA. ON (B)(6) 2023 A REVISION PROCEDURE WAS PERFORMED TO PLACE A NEW SET OF TRIAL LEADS TO BETTER TARGET THE AREA OF PAIN. IT IS UNCLEAR IF THE INITIAL LEADS MIGRATED OR WERE INCORRECTLY PLACED AT THE TIME OF IMPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17495005 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM ON (B)(6) 2022 AND SUBSEQUENTLY EXPERIENCED LOSS OF PAIN RELIEF. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE TRIAL LEADS AND RESTORE PAIN THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17446949 ↗
• InjuryAug 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR TRIAL SYSTEM ON (B)(6) 2022. WHILE IN POST-OP RECOVER IT WAS DISCOVERED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE COVERAGE OF THE TARGET PAIN AREA AND IT WAS DETERMINED THAT DURING THE IMPLANT PROCEDURE ONE OF THE IMPLANTED LEADS HAD BEEN PULLED OUT OF THE DESIRED POSITION. PATIENT WAS RETURNED TO THE OPERATING ROOM IMMEDIATELY TO RE-OPEN THE INCISION AND REPOSITION THE LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17443695 ↗
• InjuryAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS PLANNED FOR A TRIAL IMPLANT ON (B)(6) 2022. A TRIAL LEAD KIT WAS OPENED IN PREP FOR THE PROCEDURE, HOWEVER THE PROCEDURE WAS ABORTED BEFORE THE IMPLANT WAS COMPLETED. NO DETAILS WERE PROVIDED TO THE FIRM AS TO THE REASON FOR ABORTING THE PROCEDURE. IT IS UNKNOWN IF THE PATIENT WAS SEDATED OR IF INCISION WAS MADE.

  Patient problems: Insufficient Information

  MAUDE report 17433079 ↗
• InjuryJul 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR TRIAL SYSTEM ON (B)(6) 2022. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IMPLANTED LEADS. TRIAL WAS CONCLUDED SUCESSFULLY AND THE PATIENT WAS IMPLANTED WITH A PERMANENT SYSTEM ON 16MAR2022.

  Patient problems: Insufficient Information

  MAUDE report 17429877 ↗
• InjuryJul 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, PATIENT WAS PREPPED FOR A TRIAL IMPLANT OF THE NALU SPINAL CORD STIMULATOR SYSTEM. SEDATION WAS ADMINISTERED AND THE PHYSICIAN ATTEMPTED TO PLACE THE IMPLANTABLE LEADS, HOWEVER THE PATIENT'S PRE-EXISTING CONDITION OF SCOLIOSIS AND PRESENCE OF SCAR TISSUE PREVENTED THE ACCURATE PLACEMENT OF THE SYSTEM WITH THE PLANNED METHOD. THE PROCEDURE WAS ABORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17421655 ↗