Nalu Medical, Inc. 71019Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00812537037196), received between Jan 3, 2025 and Sep 28, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Migration” (23 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 57 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Wound Infection

  MAUDE report 50923446 ↗
• InjurySep 13, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50746886 ↗
• InjuryJul 27, 2026Intermittent Communication Failure

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2025, targeting bilateral superior cluneal nerves. Approximately 3 months after the implant was performed, the patient noted challenges maintaining connectivity between the Implantable Pulse Generator (IPG) and the external Therapy Discs. A Nalu representative assessed the system and reported that the IPG was difficult to palpate, indicating it had likely migrated beyond the recommended depth for optimal connectivity. On (b)(6) 2026, a surgical revision was performed to remove the migrated system and place a new system at a more superficial position.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50024266 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. AFTER THE SYSTEM WAS IMPLANTED THE PATIENT EXPERIENCED FLUID BUILDUP IN THE AREA OF THE INCISION, CAUSING THE IMPLANTED LEAD TO BE PUSHED UP THROUGH THE INCISION AND BECOME EXPOSED. ON (B)(6) 2025 THE PHYSICIAN PUSHED THE EXPOSED LEAD BACK INTO PLACE AND CLOSED THE INCISION. APPROXIMATELY 8 MONTHS AFTER REPOSITIONING THE EXPOSED LEAD, THE PATIENT REPORTED TO THE MEDICAL PROVIDER THAT THEY WERE EXPERIENCING REDNESS AND IRRITATION AROUND THE LEAD ENTRY INCISION SITE. TROUBLESHOOTING WAS PERFORMED HOWEVER THE IRRITATION PERSISTED AND THE PATIENT ELECTED TO HAVE THE SYSTEM REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2026 PER PATIENT REQUEST.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25356550 ↗
• InjuryMar 11, 2026Migration

  PATIENT WAS IMPLANTED WITH A NALU PNS SYSTEM ON (B)(6) 2025 AND THE SYSTEM WAS ACTIVATED ON (B)(6) 2025. THE SYSTEM WAS IMPLANTED WITH THE IPG PLACED IN THE LATERAL UPPER ARM AND THE LEADS TARGETING THE MEDIAN NERVE TO TREAT RIGHT LOWER ARM PAIN. THE PHYSICIAN USED BOTH FLUOROSCOPIC AND ULTRASONIC IMAGING DURING THE IMPLANT PROCEDURE. THE LEADS WERE SUTURED TO THE FASCIA AT THE TIME OF IMPLANT. AFTER USING THE SYSTEM FOR SOME TIME THE PATIENT REPORTED A SENSATION OF THE IMPLANTED LEAD "POKING" NEAR THE THUMB AREA. ASSESSMENT OF THE SYSTEM FOUND THAT THE DISTAL LEAD HAD MIGRATED A FEW CENTIMETERS. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO CORRECT THE MIGRATED LEAD. DURING THE REVISION, THE PHYSICIAN WAS ABLE TO RETRACT THE MIGRATED LEADS AND RETURN THEM TO THEIR ORIGINAL POSITION. THE LEADS WERE THEN SUTURED DOWN TO THE FASCIA AGAIN TO SECURE PLACEMENT.

  Patient problems: Discomfort

  MAUDE report 24570092 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT SHOULDER PAIN. THE IPG WAS PLACED IN THE RIGHT POSTERIOR SHOULDER AREA WITH THE LEADS TARGETING THE SUPRASCAPULAR NERVE. AFTER IMPLANTING THE SYSTEM, THE PATIENT EXPERIENCED ONGOING ISSUES WITH HEALING AND UNDERWENT MULTIPLE ROUNDS OF ANTIBIOTICS TO TREAT INFECTION THAT DEVELOPED AT THE OPEN INCISION SITE. THE INCISION WAS CLEANED AND RE-CLOSED APPROXIMATELY 4 TIMES AFTER THE IMPLANT BEFORE THE PHYSICIAN DETERMINED THAT THE NALU SYSTEM WOULD NEED TO BE REMOVED. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO ONGOING ISSUES WITH HEALING AFTER THE IMPLANT.

  Patient problems: Impaired Healing

  MAUDE report 24570091 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  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 CLUNEAL NERVES. ON (B)(6) 2025 A SURGICAL REVISION TOOK PLACE TO REPOSITION MIGRATED LEADS (SEE MDR 3015425075-2025-00218). AFTER THE REVISION, THE SURGICAL INCISION SITE FAILED TO HEAL AS EXPECTED. ON(B)(6) 2026 THE SYSTEM WAS FULLY EXPLANTED AND A NEW SYSTEM WAS PLACED IN A SLIGHTLY DIFFERENT POSITION TO ENCOURAGE THE PREVIOUS SITE TO HEAL.

  Patient problems: Impaired Healing

  MAUDE report 24474836 ↗
• InjuryFeb 21, 2026Migration

  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 WITH THE LEADS TARGETING THE CLUNEAL NERVE. AFTER SEVERAL MONTHS OF USING THE SYSTEM, THE PATIENT REPORTED INCREASE IN PAIN SYMPTOMS IN THE BACK. REPROGRAMMING WAS NOT ABLE TO SUCCESSFULLY ADDRESS THE SYMPTOMS. XRAY IMAGING WAS DONE AND FOUND THAT BOTH LEADS HAD MIGRATED TOWARD THE PATIENT'S SI JOINTS FROM THE CLUNEAL NERVE PLACEMENT. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS AT THE INTENDED NERVE TARGET. DURING THE PROCEDURE THE IPG WAS NOT ABLE TO BE SUCCESSFULLY CONNECTED WITH THE NEW LEADS AND ULTIMATELY THE IPG REQUIRED REPLACEMENT AS WELL.

  Patient problems: Implant Pain

  MAUDE report 24409204 ↗
• InjuryFeb 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM IN IDAHO ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. AFTER IMPLANTING THE SYSTEM, THE PATIENT WAS SEEN SEVERAL TIMES BY LOCAL NALU REPRESENTATIVES FOR TYPICAL SYSTEM REPROGRAMMING. DURING THOSE APPOINTMENTS THE PATIENT HAD EXPRESSED INADEQUATE RELIEF WHICH WAS ATTEMPTED TO BE ADDRESSED THROUGH PROGRAMMING. AFTER THE IMPLANT AND SEVERAL REPROGRAMMING SESSIONS, THE PATIENT RELOCATED TO A DIFFERENT STATE AND WAS NO LONGER IN CONTACT WITH NALU PERSONNEL. IN DECEMBER 2025 THE FIRM WAS NOTIFIED BY A MEDICAL FACILITY IN ARIZONA THAT THE PATIENT WAS SCHEDULED FOR EXPLANT OF THEIR NALU SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2026 AS PLANNED. SCHEDULING CONFLICTS PREVENTED ANY NALU PERSONNEL FROM BEING PRESENT FOR THE PROCEDURE AND THE EXPLANTED COMPONENTS WERE NOT RETAINED FOR RETURN TO THE FIRM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24341649 ↗
• InjuryJan 24, 2026Intermittent Communication Failure

  ON (B)(6) 2025 A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED TO REPLACE A PRE-EXISTING NEUROSTIMULATION SYSTEM FROM A DIFFERENT MANUFACTURER. THE NALU SYSTEM WAS PLACED SUCH THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IN THE UPPER LATERAL SHOULDER AREA WITH THE LEADS TARGETING THE OCCIPITAL NERVES. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR SURGICAL PROCEDURE TO MOVE THE IMPLANTABLE PULSE GENERATOR (IPG) TO LOWER ON THE SHOULDER AND MORE MEDIAL TO BETTER SUPPORT CONSISTENT CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. DURING THE PROCEDURE A MIGRATED LEAD WAS ALSO REPOSITIONED TO BE AT THE INTENDED LOCATION TO PROVIDE THERAPY AT THE SITE OF PAIN. APPROXIMATELY 1 MONTH AFTER THE REVISION, THE PATIENT REPORTED CONTINUING CHALLENGES IN MAINTAINING CONNECTION BETWEEN THE IPG AND THERAPY DISCS. ON (B)(6) 2025 THE PATIENT WAS SEEN IN THE CLINIC AND XRAY IMAGING FOUND THAT THE IPG HAD MIGRATED BEYOND THE RECOMMENDED DEPTH. ON (B)(6) 2025 A SECOND SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED IPG AND PLACE A NEW ONE IN A MORE SUPERFICIAL POSITION. DURING THE PROCEDURE THE LEADS WERE ALSO REPLACED OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24173455 ↗
• InjuryJan 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO SUSPECTED INFECTION AT THE IMPLANT SITE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24173454 ↗
• InjuryJan 24, 2026Impedance Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AND THE SYSTEM WAS ACTIVATED ON (B)(6) 2024. IN (B)(6) 2025 THE PATIENT WAS SEEN FOR A REPROGRAMMING DUE TO REDUCED EFFICACY, AND THE SYSTEM RETURNED OPEN CIRCUIT IMPEDANCE ERRORS. REPROGRAMMING WAS COMPLETED AND NO FURTHER INTERVENTIONS WERE REQUESTED AT THAT TIME. IN (B)(6) 2025 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS PLANNING TO UNDERGO AN MRI SCAN AND WOULD REQUIRE SURGICAL INTERVENTION DUE TO THE PRESENCE OF IMPEDANCE ERRORS WITHIN THE NALU SYSTEM. ON (B)(6) 2025 A FULL SYSTEM EXPLANT TOOK PLACE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24173453 ↗
• InjuryJan 20, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. ON (B)(6) 2025 A NALU REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT WAS BEING SCHEDULED FOR A SURGICAL REVISION DUE TO LEAD MIGRATION. ON (B)(6) 2025 THE MIGRATED LEAD WAS REMOVED AND A NEW LEAD WAS PLACED BACK AT THE INTENDED LOCATION. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24114339 ↗
• InjuryNov 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. ON (B)(6) 2025, THE FIRM BECAME AWARE THAT THE PATIENT HAD BEEN ADMITTED TO AN ACUTE HOSPITAL ON (B)(6) 2025 DUE TO CONCERNS OF POSSIBLE INFECTION. THE PATIENT REPORTS EXPERIENCING PAIN AT THE AREA OF THE IMPLANT AND DEVELOPING A FEVER DESPITE HAVING BEEN ADMINISTERED ANTIBIOTICS PROPHYLACTICALLY AT THE TIME OF IMPLANT. ON (B)(6) 2025, A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO INFECTION CONCERNS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23563543 ↗
• InjuryNov 5, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. THE PATIENT PARTICIPATED IN A SUCCESSFUL TRIAL PHASE WITH NALU PRIOR TO IMPLANTING A PERMANENT SYSTEM. UPON ACTIVATING THE PERMANENT SYSTEM THE PATIENT REPORTED NOT GETTING SUFFICIENT PAIN RELIEF. MULTIPLE ATTEMPTS WERE MADE TO REPROGRAM THE SYSTEM TO OPTIMIZE THERAPY WITH NO SUCCESS, LEADING TO FURTHER FRUSTRATION FROM THE PATIENT. IMAGING IS REPORTED TO HAVE BEEN DONE BY THE IMPLANTING PHYSICIAN AND FOUND LEADS HAD MIGRATED. ON (B)(6) 2025 A DIFFERENT PHYSICIAN PERFORMED A SURGICAL REVISION TO REMOVE THE NON-TINED SYSTEM AND PLACE A NEW SYSTEM WITH TINED LEADS TO PROVIDE IMPROVED STABILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23473184 ↗
• InjuryOct 27, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT UPPER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE INTERCOSTAL NERVE. BEGINNING MID-YEAR 2025 THE PATIENT BEGAN TO REPORT INCONSISTENT CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING IN THE FIELD WAS UNABLE TO RESOLVE THE ISSUE AND CONCLUDED THAT THE IPG HAD MIGRATED WITHIN THE POCKET TO NO LONGER BE PARALLEL TO THE SKIN SURFACE. THE POSITION OF THE IPG WAS DETERMINED TO BE AFFECTING COMMUNICATION BETWEEN DEVICES. THE PATIENT REQUESTED TO TRANSITION FROM THE NALU DEVICE WITH EXTERNAL WEARABLES TO A FULLY IMPLANTED DEVICE FROM A DIFFERENT MANUFACTURER. ON (B)(6) 2025 THE NALU SYSTEM WAS REMOVED AND A NEUROSTIMULATION DEVICE FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. THE PROCEDURE IS REPORTED TO HAVE GONE SMOOTHLY AND THE NEW SYSTEM WAS COVERING THE AREAS OF PAIN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23398373 ↗
• InjuryOct 19, 2025Migration; Intermittent Communication Failure; Migration; Intermittent Communication Failure

  ON (B)(6) 2025 A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED TO REPLACE A PRE-EXISTING NEUROSTIMULATION SYSTEM FROM A DIFFERENT MANUFACTURER. THE NALU SYSTEM WAS PLACED SUCH THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IN THE UPPER LATERAL SHOULDER AREA WITH THE LEADS TARGETING THE OCCIPITAL NERVES. THE PATIENT PARTICIPATED IN A WEAR STUDY PRIOR TO IMPLANTING THE NALU SYSTEM AND CONFIRMED BEING HAPPY WITH THE PLACEMENT OF THE EXTERNAL COMPONENTS, HOWEVER THE LOCATION OF THE SYSTEM WAS CAUSING CONNECTIVITY ISSUES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. THE CONNECTIVITY ISSUES WERE CAUSING DISRUPTIONS IN THERAPY EACH TIME THE PATIENT WOULD LIFT THE ARM TO DO ACTIVITIES SUCH AS EXERCISING OR REACHING ABOVE THE HEAD. THE PATIENT ALSO REPORTED THAT THE STIMULATION WAS BEING FELT LOWER THAN THE TARGETED PAIN AREA. THE PHYSICIAN PERFORMED FLOUROSCOPIC IMAGING AND NOTED THAT THE RIGHT-SIDE LEAD HAD MIGRATED DOWN AWAY FROM THE INTENDED TARGET. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR SURGICAL PROCEDURE TO REPOSITION THE MIGRATED LEAD AND THE IPG. THE RIGHT LEAD WAS PUSHED BACK UP TO THE INTENDED LOCATION AND THE IPG WAS MOVED LOWER ON THE SHOULDER AND MORE MEDIAL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23334092 ↗
• InjuryOct 15, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE ANTERIOR THIGH AREA WITH THE LEADS TARGETING THE GENICULAR NERVES. ON (B)(6) 2025 THE PATIENT WAS SEEN BY A NALU REPRESENTATIVE IN THE MEDICAL CLINIC AND THE NALU SYSTEM WAS NOTED TO HAVE IMPEDANCE ERRORS ON ONE CONTACT OF ONE LEAD. AT THE TIME OF THE VISIT THE PATIENT REPORTED RECEIVING ADEQUATE STIMULATION, HOWEVER THE PHYSICIAN ORDERED XRAY IMAGING TO VERIFY LEAD PLACEMENT. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED DUE TO MIGRATION OF THE IMPLANTED LEAD AS WELL AS IMPEDANCE ERRORS IN THE SYSTEM. DURING THE REVISION THE IPG AND SECOND LEAD WERE ALSO REPLACED OUT OF CAUTION ALTHOUGH THERE ARE NO REPORTS OF ANY FAILURE OR MALFUNCTION OF THOSE COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306107 ↗
• InjuryOct 12, 2025Impedance Problem; Migration; Impedance Problem; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2025. IN (B)(6)2025 THE PATIENT REPORTED FEELING A PULLING SENSATION WHEN SITTING DOWN ONTO A TOILET AND THOUGHT IT WAS POSSIBLY THE NALU LEAD. AFTER THAT EVENT THE SYSTEM WAS ASSESSED AND FOUND TO HAVE OPEN CIRCUIT IMPEDANCE READINGS ON THAT SUSPECTED LEAD. THE SYSTEM WAS REPROGRAMMED TO WORK AROUND THE AFFECTED CONTACT ON THAT LEAD AND THE PATIENT REPORTED GOOD THERAPY AT APPROPRIATE LOCATION. AFTER THAT REPROGRAMMING SESSION, THE PATIENT REPORTED DECREASE IN THERAPY. FIELD ASSESSMENT BY THE IMPLANTING PHYSICIAN DETERMINED THAT THE LEAD HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON (B)(6)2025 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE AFFECTED LEAD AND PLACE A NEW LEAD AT THE TARGET NERVE LOCATION. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) AND SECOND LEAD WERE ALSO REPLACED TO AVOID POTENTIAL HANDLING DAMAGE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23275760 ↗
• InjurySep 15, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BILATERAL LOWER BACK PAIN. THE SYSTEM WAS SUCCESSFULLY ACTIVATED ON (B)(6) 2025. A SURVEY COMPLETED BY THE PATIENT ON (B)(6) 2025 INDICATES THE PATIENT HAD RECEIVED APPROXIMATELY (B)(4) REDUCTION IN PAIN SYMPTOMS. DURING A ROUTINE FOLLOW-UP VISIT AT THE MEDICAL CLINIC ON (B)(6) 2025 THE PATIENT REPORTED THAT THERE WAS A LOSS OF EFFICACY ON THE RIGHT SIDE OF THE BACK. XRAY IMAGING PERFORMED AT THAT VISIT FOUND THAT THE RIGHT LEAD HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED LEAD AND PLACE A NEW LEAD AT THE INTENDED NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23048214 ↗
• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. DURING A MEDICAL CLINIC VISIT ON (B)(6) 2025 THE PHYSICIAN NOTED THAT THE SURGICAL INCISION WAS OPEN AND VISUALLY APPEARED INFECTED. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE INFECTION AND FAILURE TO HEAL. THE EXPLANT SCHEDULE WAS NOT COMMUNICATED TO THE FIRM PRIOR TO THE EVENT AND THUS NO NALU REPRESENTATIVES WERE PRESENT FOR THE PROCEDURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22881404 ↗
• InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT SHOULDER PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH THE IMPLANTED LEADS TARGETING THE LEFT SUPRASCAPULAR NERVE. AFTER IMPLANTING THE SYSTEM, THE PATIENT DEVELOPED INFECTION AT THE IPG INCISION SITE AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22881255 ↗
• InjuryAug 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. ON (B)(6) 2025 THE FIRM WAS CONTACTED BY AN MRI FACILITY TO REQUEST MRI CONDITIONALITY OF THE NALU SYSTEM. THE FACILITY WAS ADVISED THAT THE PATIENT IS NOT CONDITIONAL DUE TO THE PRESENCE OF BOTH THE NALU ACTIVE IMPLANTED SYSTEM AND A SECOND ACTIVE IMPLANTED SYSTEM FROM A DIFFERENT MANUFACTURER. DURING A CLINIC VISIT ON (B)(6) 2025 FOR REPROGRAMMING, THE NALU SYSTEM RETURNED IMPEDANCE ERRORS INDICATING AN OPEN CIRCUIT. THE PATIENT WAS INITIALLY SCHEDULED TO HAVE A REVISION PROCEDURE TO REPLACE POSSIBLE MALFUNCTIONING COMPONENTS, HOWEVER THE PATIENT ELECTED TO FULLY REMOVE THE SYSTEM SO THAT THEY COULD MOVE FORWARD WITH MRI SCANS FOR A POSSIBLE CANCER DIAGNOSIS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881252 ↗
• InjuryAug 14, 2025Overheating of Device; Overheating of Device

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LATERAL THIGH AREA WITH THE IMPLANTED LEADS TARGETING THE SCIATIC NERVE. IN (B)(6) 2025, THE PATIENT REPORTED FEELING SOME HEATING SENSATION AT THE SITE OF THE IPG. THE PATIENT REPORTED THE SENSATION WAS ONLY FELT WHEN STIMULATION WAS RUNNING. THE PHYSICIAN EVALUATED THE PATIENT AND FOUND NO SIGNS OF ANY SKIN REACTION OR RASH. PHYSICIAN DID RECOMMEND THE PATIENT USE A STEROID SKIN CREAM AT THE SITE OF THE ADHESIVE CLIP. THE SKIN CREAM WAS NOT SUCCESSFUL IN ADDRESSING THE HEATING SENSATION AND IN (B)(6) 2025 THE PATIENT WAS ADVISED TO STOP USING THE SYSTEM FOR SOME TIME TO SEE IF THE SYMPTOMS RESOLVED AFTER TAKING A BREAK. ISSUE WAS NOT RESOLVED. THE NALU SYSTEM WAS TESTED FOR IMPEDANCE ISSUES AND RETURNED GOOD READINGS, ALL COMPONENTS APPEARED TO BE FUNCTIONING AS EXPECTED. CAUSE OF THE HEATING YET UNDETERMINED, HOWEVER THE PHYSICIAN NOTED SUSPICION OF THE HEATING BEING RELATED TO DEVELOPMENT OF SCAR TISSUE AT THE IPG SITE. THE PATIENT DECLINED PHYSICIAN RECOMMENDATION FOR STEROID INJECTION AT THE SITE. ON (B)

  Patient problems: Discomfort

  MAUDE report 22801719 ↗
• InjuryAug 10, 2025Lack of Effect; Lack of Effect

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. ALL RECORDS APPEAR TO INDICATE THAT THE TRIAL PHASE WITH NALU WAS SUCCESSFUL, LEADING TO IMPLANT OF A PERMANENT SYSTEM. ON (B)(6) 2025 THE PATIENT REPORTED TO A NALU REPRESENTATIVE THAT THE SYSTEM HAD NOT BEEN USED SINCE APPROXIMATELY (B)(6) 2025 DUE TO DISSATISFACTION WITH USABILITY AND THERAPY BEING RECEIVED AND THE PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22768326 ↗