Nalu Medical, Inc. 72007 (UDI 00812537037387)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00812537037387), received between Nov 9, 2024 and Apr 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 WITH THE SYSTEM TARGETING THE MEDIAL BRANCH NERVE. ON (B)(6) 2025, THE PATIENT REPORTED SOME DISCOMFORT, NOTING THAT STIMULATION FROM THE NALU SYSTEM SEEMED TO BE FELT BEYOND THE INTENDED TARGET AREA. THE PATIENT WAS SEEN IN THE MEDICAL CLINIC AND XRAY IMAGING CONFIRMED ONE OF THE LEADS HAD MIGRATED AWAY FROM THE ORIGINAL IMPLANT LOCATION. THE SYSTEM WAS REPROGRAMMED TO USE ONLY THE SINGLE LEAD THAT WAS NOT CAUSING DISCOMFORT; HOWEVER, USE OF THE SINGLE LEAD WAS NOT ABLE TO PROVIDE SUFFICIENT PAIN RELIEF FOR THE PATIENT. ON (B)(6) 2026, THE PATIENT WAS SEEN FOR SURGICAL REVISION TO REPLACE THE MIGRATED LEAD. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR WAS ALSO REPLACED OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24971728 ↗
• InjuryMar 30, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BACK PAIN. ON (B)(6) 2026 THE PATIENT PRESENTED AT THE MEDICAL CLINIC WITH COMPLAINTS OF PAIN IN THE RIGHT LEG. ASSESSMENT BY THE PHYSICIAN DETERMINED THAT THE LEAD HAD MIGRATED AND WAS PLACING PRESSURE ON THE EXITING NERVE ROOT, CAUSING THE PAIN SYMPTOMS. ADDITIONALLY, THE REPORTED PAIN PATTERN THAT WAS INTENDED TO BE TREATED WITH THE NALU SYSTEM WAS ASSESSED AND DETERMINED THAT THE PLACEMENT OF THE SYSTEM WAS NOT APPROPRIATE FOR THE PATTERN. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO CORRECT THE LEAD PLACEMENT. THE PATIENT HAD INITIALLY BEEN IMPLANTED WITH THE IMPLANTABLE PULSE GENERATOR (IPG) PLACED IN THE LOWER BACK WITH THE LEADS TARGETING THE L3 AREA OF THE MEDIAL BRANCH NERVE. TINED LEADS WERE USED AND THE LEADS WERE ALSO SUTURED IN PLACE. THE REVISING PHYSICIAN WAS ABLE TO FULLY REMOVE THE MIGRATED LEAD AS WELL AS THE SECOND LEAD AND IPG. THE SYSTEM WAS REPLACED WITH BILATERAL SUPERIOR CLUNEAL PLACEMENT WITH THE IPG REMAINING IN THE FLANK AREA BUT SLIGHTLY MORE LATERAL ON THE LEFT SIDE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 24722392 ↗
• InjuryNov 22, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT OFF-LABEL MIGRAINE RELATED TO HEAD AND NECK PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED FREQUENT COMMUNICATION ISSUES BETWEEN THE IPG AND EXTERNAL THERAPY DISCS. PATIENT ALSO REPORTED INADEQUATE PAIN RELIEF WHILE THE SYSTEM WAS CONNECTED AND RUNNING STIMULATION. MULTIPLE SURGICAL INTERVENTIONS WERE DONE, INCLUDING REPOSITIONING THE EXISTING IMPLANT ON (B)(6) 2025 (SEE MDR 3015425075-2025-00260) AND A SECOND RELOCATION OF THE IMPLANT AS WELL AS REPLACEMENT OF THE LEADS ON (B)(6) 2025 (SEE MDR 3015425075-2025-00254). DURING THE PROCEDURE IN (B)(6) 2025 THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RELOCATED FROM THE INTRACLAVICULAR AREA TO THE POSTERIOR SHOULDER AREA TO PROVIDE MORE STABLE TISSUE TO SUPPORT THE IMPLANT. ON (B)(6) 2025 THE FIRM WAS NOTIFIED THAT THE PATIENT'S PAIN SYMPTOMS HAD AGAIN INCREASED. THE PHYSICIAN USED IMAGING TO CONFIRM THE NEW LEADS THAT WERE PLACED AT THE OCCIPITAL NERVE HAD MIGRATED. THE PHYSICIAN NOTED THAT THERE WAS NO SUSPICION OF ANY COMPONENT MALFUNCTION SO THE PLAN WOULD BE TO REPOSITION THE EXISTING OCCIPITAL LEAD. DURING THE PROCEDURE ON (B)(6

  Patient problems: Inadequate Pain Relief

  MAUDE report 23626743 ↗
• InjuryOct 27, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BACK PAIN. DURING THE IMPLANT PROCEDURE, THE PHYSICIAN VERBALIZED SOME CONCERN AROUND THE PLACEMENT OF THE COMPONENTS. THE DECISION WAS MADE AT THAT TIME TO LEAVE THE COMPONENTS AS PLACED DUE TO THE DEPLOYMENT OF THE TINED LEADS. UPON ACTIVATING THE SYSTEM, THE PATIENT REPORTED FEELING STIMULATION IN THE GROIN AND LEG INSTEAD OF THE BACK. ADDITIONALLY, THE PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS FOUND TO BE IN AN AREA OF SKIN ROLLS, WHICH LED TO DISRUPTIONS IN COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS AS THE PATIENT'S SKIN SHIFTED DURING POSITIONAL CHANGES. ON (B)(6) 2025, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE RIGHT LEAD AND PLACE A NEW LEAD TO BETTER TARGET THE AREA OF PAIN. ALSO, DURING THE PROCEDURE, THE IPG WAS REMOVED AND A NEW IPG WAS PLACED IN A NEW POCKET LOCATION THAT IS MORE MEDIAL AND PROVIDES MORE STABLE TISSUE AND SKIN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23398375 ↗
• InjuryAug 10, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE L3 VERTEBRAL BODY AREA OF THE MEDIAL BRANCH NERVE. IN (B)(6) 2025 THE PATIENT NOTIFIED A NALU REPRESENTATIVE THAT THERE WAS A LOSS OF THERAPY ON THE LEFT SIDE OF THE BACK. REMOTE CHECK OF THE SYSTEM FOUND OPEN CIRCUIT IMPEDANCE READINGS ON THE LEFT SIDE LEAD. THE PATIENT WAS ADVISED TO SCHEDULE A CLINIC VISIT AND DURING THE VISIT THE SYSTEM WAS CONFIRMED TO HAVE IMPEDANCE ISSUES ON ONE LEAD. IMAGING WAS PERFORMED AND SHOWED NO OBVIOUS DAMAGE OR MIGRATION OF THE AFFECTED LEAD. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REPLACE ONLY THE MALFUNCTIONING LEAD. THE IPG AND SECOND LEAD REMAIN IMPLANTED AND IN USE WHILE A NEW LEAD WAS IMPLANTED TO REPLACE THE MALFUNCTIONING LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22768338 ↗
• InjuryAug 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE PATIENT HAD PARTICIPATED IN A SUCCESSFUL TRIAL PHASE WITH NALU PRIOR TO THE IMPLANT. THE PATIENT WAS ALSO AN ACTIVE PARTICIPANT IN CHOOSING THE LOCATION FOR THE IMPLANT PER A WEAR STUDY PERFORMED WITH NALU. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA AT THE PATIENT'S CHOSEN LOCATION, HOWEVER THE PATIENT LATER REPORTED DISCOMFORT AT THE SITE AND REQUESTED EXPLANT. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: Discomfort

  MAUDE report 22768333 ↗
• InjuryJul 14, 2025Migration; Migration

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2025 TO TREAT BILATERL LOWER BACK PAIN. AFTER ACTIVATING AND USING THE SYSTEM, THE PATIENT REPORTED LOSS OF PAIN RELIEF ON THE LEFT SIDE. IMAGING FOUND THAT ONE OF THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE MIGRATED LEAD. DURING THE PROCEDURE THE PHYSICIAN ALSO REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE SECOND LEAD, DESPITE NO PROBLEMS REPORTED WITH THOSE COMPONENTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22493904 ↗
• InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT RIGHT SIDE LOWER BACK PAIN. IN (B)(6) 2025 THE FIRM WAS NOTIFIED THAT THE PHYSICIAN SUSPECTED THE SITE TO BE INFECTED AND PLANNED TO REMOVE THE SYSTEM. ON (B)(6) 2025 THE PATIENT WAS BROUGHT TO THE SURGICAL SITE AND THE PHYSICIAN FOUND THAT THERE WERE ACTUALLY NO SIGNS OF INFECTION BUT THAT THE IMPLANTED LEAD HAD ERODED THROUGH THE SKIN AT ONE LOCATION. THE PHYSICIAN WAS ABLE TO REPOSITION THE LEAD AND SUTUR IT TO THE FASCIA, THEN CLOSE THE SKIN, NO COMPONENTS WERE REMOVED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE INTRODUCED. THE NALU SYSTEM REMAINS IMPLANTED AND IN USE AT THE TIME OF REPORTING.

  Patient problems: Skin Erosion

  MAUDE report 22178973 ↗
• InjuryNov 9, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT ABDOMINAL PAIN. PRIOR TO IMPLANTING THE PERMANENT SYSTEM, THE PATIENT HAD COMPLETED A TRIAL PHASE WITH NALU AND HAD REPORTED PAIN REDUCTION FROM (B)(6) DOWN TO (B)(6). DURING THE IMPLANT PROCEDURE TO PLACE THE PERMANENT SYSTEM, BOTH ULTRASOUND AND FLUORSCOPY IMAGING WERE USED TO IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) IN THE LOWER BACK AND PLACE THE LEADS TARGETING THE INTERCOSTAL NERVE, MIMICKING THE TRIAL SYSTEM PLACEMENT. PATIENT RETURNED TO THE CLINIC FOR SYSTEM ACTIVATION ON (B)(6) 2024 AND WAS NOT ABLE TO ACHIEVE THE SAME LEVELS OF PAIN RELIEF AS EXPERIENCED DURING THE TRIAL. BETWEEN (B)(6) 2024 AND (B)(6) 2024 THE PATIENT HAD MULTIPLE APPOINTMENTS TO REPROGRAM THE SYSTEM TO IMPROVE THERAPY. FLUOROSCOPIC IMAGING CONFIRMED THAT THE SUPERIOR LEAD HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON (B)(6) 2024 A SURGICAL REVISION TOOK PLACE TO ATTEMPT TO REPLACE THE MIGRATED LEAD. DURING THE REVISION PROCEDURE, THE PHYSICIAN UTILIZED ULTRASOUND IMAGING TO VISUALIZE THE LOCATION OF THE MIGRATED LEAD IN ORDER TO RETRIEVE IT AND PLACE THE NEW LEAD. A TOTAL OF 3 INCISIONS WERE MADE IN

  Patient problems: Inadequate Pain Relief

  MAUDE report 20647682 ↗