Nalu Medical, Inc. 71004 (UDI 00812537037349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00812537037349), received between Nov 22, 2024 and Sep 13, 2026 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (8 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746888 ↗
• InjurySep 13, 2026Intermittent Communication Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50746887 ↗
• MalfunctionSep 11, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744648 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Erosion

  MAUDE report 50744647 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Erosion

  MAUDE report 50744645 ↗
• InjuryAug 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2026 to treat shoulder pain. The Implantable Pulse Generator (IPG) was placed in the posterior shoulder area with the leads targeting the suprascapular nerves. After using the system for several months the patient elected to move forward with surgery to the shoulder being treated by the Nalu system. In preparation for the planned procedure, the Nalu system was surgically explanted on (b)(6) 2026 per patient request.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184722 ↗
• InjuryApr 17, 2026Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TO TREAT LOWER BACK PAIN. AT THE TIME OF SYSTEM ACTIVATION THE NALU REPRESENTATIVE WAS ABLE TO CONNECT ALL SYSTEM COMPONENTS APPROPRIATELY AND PATIENT WAS SENT HOME WITH THERAPY. WITHIN SEVERAL DAYS OF ACTIVATION THE PATIENT REACHED OUT TO REPORT FREQUENT DISCONNECTIONS AND FRUSTRATION. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE CONNECTIVITY ISSUES AND ULTIMATELY IMAGING FOUND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MIGRATED BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTION WITH THE EXTERNAL COMPONENTS. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2026 TO CREATE A NEW POCKET IN A SLIGHTLY DIFFERENT LOCATION ON THE PATIENT'S RIGHT LOWER BACK AND IMPLANT A NEW IPG IN THE NEW POCKET LOCATION. DURING THE PROCEDURE THE LEADS WERE ALSO REPLACED OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24909465 ↗
• InjuryApr 6, 2026Intermittent Communication Failure

  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 NERVE. AFTER HAVING THE SYSTEM IN USE FOR SEVERAL MONTHS THE IPG WAS FOUND TO HAVE MIGRATED BEYOND THE RECOMMENDED DEPTH, CAUSING CONNECTIVITY ISSUES WITH THE THERAPY DISCS. WHILE ASSESSING THE IMPLANTED SYSTEM IT WAS ALSO DISCOVERED THAT THE LEADS HAD MIGRATED AWAY FROM THE ORIGINAL PLACEMENT. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO PLACE THE IPG SLIGHTLY HIGHER ON THE BACK TO A MORE FLAT AND LESS FATTY LOCATION AND REPOSITION THE LEADS TO THEIR INTENDED LOCATION. DURING THE PROCEDURE THE IMPLANT SUSTAINED HANDLING DAMAGE AND REQUIRED REPLACEMENT OF ALL COMPONENTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24794496 ↗
• InjuryMar 30, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BACK PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT LATER REPORTED SOME DIFFICULTIES MAINTAINING CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR AND THE EXTERNAL THERAPY DISCS. ASSESSMENT WHILE THE DEVICE REMAINED IMPLANTED DETERMINED THAT THE IPG HAD MIGRATED BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY AND HAD ALSO ROTATED TO NO LONGER BE SEATED PARALLEL TO THE SKIN SURFACE. VARIOUS METHODS OF EXTERNAL DEVICE FIXATION WERE ATTEMPTED AS TROUBLESHOOTING AND FAILED TO IMPROVE THE CONNECTIVITY BETWEEN DEVICES. ON (B)(6) 2026, A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED SYSTEM AND PLACE A NEW NALU SYSTEM AT THE INTENDED NERVE TARGET AND WITH THE IPG PLACED SUPERFICIALLY AND PARALLEL TO THE SKIN SURFACE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24722348 ↗
• 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 LOWER BACK PAIN. AFTER IMPLANTING THE SYSTEM, THE SURGICAL INCISION SITE FAILED TO HEAL AS EXPECTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND REFERRED TO A WOUND CARE SPECIALIST, WHO TREATED THE SITE FOR SEVERAL WEEKS WITHOUT SUCCESS. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO UNRESOLVED SYMPTOMS OF INFECTION AND POOR WOUND HEALING.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24575508 ↗
• InjuryMar 9, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE CLUNEAL NERVE. THE LEADS WERE ANCHORED USING SUTURES AS OPPOSED TO AN ANCHORING DEVICE DUE TO THE PATIENT'S LOW BMI AND PHYSICIAN CONCERN OF ADDING ANY ADDITIONAL COMPONENTS INTO A LIMITED SPACE. AFTER USING THE SYSTEM FOR SOME TIME THE PATIENT BEGAN TO NOTICE SOME DISCOMFORT AT THE PSIS AREA, MOST PRONOUNCED WHEN LAYING SUPINE ON A MAT TO DO PILATES. IMAGING CONFIRMED THE LEAD HAD MIGRATED SLIGHTLY AND THE MIGRATION WAS LIKELY CAUSING THE DISCOMFORT. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE EXISTING LEADS. THE LEADS WERE AGAIN SURTURED INTO PLACE.

  Patient problems: Discomfort

  MAUDE report 24554245 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. AFTER IMPLANTING THE SYSTEM THE SURGICAL SITE FAILED TO HEAL COMPLETELY. THE PATIENT DEVELOPED AN INFECTION AND THE IMPLANTED LEADS BECAME EXPOSED. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS COMPLETED DUE TO INFECTION AND EXPOSED LEAD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24554244 ↗
• InjuryMar 7, 2026Improper or Incorrect Procedure or Method

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT UPPER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE MID-BACK AREA WITH THE LEADS TARGETING THE MEDIAL BRANCH NERVE. AFTER ACTIVATING THE SYSTEM, THE PATIENT HAD REPORTED RECEIVING GOOD THERAPY AND NO FURTHER COMMUNICATION WAS RECEIVED FROM T HE PATIENT. IN (B)(6) 2026 THE FIRM WAS NOTIFIED OF A PLANNED PROCEDURE FOR THIS PATIENT AND WAS INFORMED BY THE PHYSICIAN THAT THE PATIENT HAD COMPLAINED OF DISCOMFORT AT THE IMPLANT SITE. PHYSICIAN EVALUATION DETERMINED THAT THE IMPLANT WAS PLACED TOO SUPERFICIAL AND THAT WAS CAUSING THE REPORTED DISCOMFORT. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPG AND PLACE A NEW IPG IN A NEW POCKET CREATED AT A SLIGHTLY DEEPER POSITION TO IMPROVE PATIENT COMFORT.

  Patient problems: Discomfort

  MAUDE report 24539886 ↗
• InjuryFeb 24, 2026Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER EXTREMITY PAIN. THE SYSTEM WAS ACTIVATED WITH NO ISSUES AND THE PATIENT USED THE SYSTEM FOR APPROXIMATELY ONE MONTH BEFORE NOTING ONSET OF CONNECTIVITY ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. THE PATIENT NOTIFIED A NALU REPRESENTATIVE OF THE CONNECTIVITY ISSUES ON (B)(6) 2025 AND WAS SEEN FOR TROUBLESHOOTING AND ASSESSMENT. WHILE ASSESSING THE SYSTEM, IMAGING FOUND THAT THE IPG HAD MIGRATED TO BE BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY. ON (B)(6) 2026 THE IPG WAS REMOVED AND A NEW IPG WAS PLACED IN A MORE SUPERFICIAL POCKET TO IMPROVE CONNECTIVITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24438745 ↗
• InjuryFeb 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT ABDOMINAL PAIN. AFTER ACTIVATING THE SYSTEM IT WAS DISCOVERED THAT THE IMPLANT LOCATION DID NOT PROVIDE ADEQUATE TISSUE QUALITY TO SUPPORT STABILITY OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND ON (B)(6) 2025 THE IPG WAS REMOVED AND A NEW ONE WAS PLACED IN A NEW POCKET LOCATION. SEE MDR 3015425075-2025-00343 ON (B)(6) 2025 THE PATIENT CONTACTED THE FIRM TO REPORT ONSET OF PAIN AT THE IMPLANT SITE, INCLUDING SWELLING AND REDNESS. DURING THE CONVERSATION THE PATIENT DISCLOSED HAVING EXPERIENCED EXTREME PAIN AT THE IMPLANT LOCATION ON (B)(6) 2025 FOR WHICH THE PATIENT REPORTED HAVING BEEN SEEN AT A LOCAL HOSPITAL AND GIVEN MORPHINE TO ADDRESS. PATIENT WAS ADVISED TO CONTACT THE MEDICAL DOCTOR FOR FOLLOW UP. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE REPORTED SYMPTOMS.

  Patient problems: Implant Pain

  MAUDE report 24341651 ↗
• InjuryFeb 12, 2026Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LATERAL THIGH AREA WITH THE LEADS TARGETING THE SCIATIC AND SAPHENOUS NERVES. AFTER ACTIVATING THE SYSTEM, THE PATIENT NOTED ISSUES MAINTAINING CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, SPECIFICALLY REPORTING LOSS OF CONNECTION UPON MOVING TO A STANDING POSITION. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE EXISTING IPG DUE TO SUSPECTED DEPTH OR POSITIONAL ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24329715 ↗
• InjuryDec 14, 2025Impedance Problem; Intermittent Communication Failure; Impedance Problem; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT ABDOMINAL PAIN AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. DURING THE IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE ABDOMEN AREA WITH THE LEADS TARGETING THE INTERCOSTAL NERVES. THE SYSTEM WAS ACTIVATED AND FUNCTIONAL, HOWEVER AFTER SEVERAL DAYS OF USING THE SYSTEM THE PATIENT REPORTED CHALLENGES WITH MAINTAINING CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. ASSESSMENT OF THE SYSTEM IDENTIFIED OPEN CIRCUIT IMPEDANCE ERRORS ON 3 ELECTRODES OF ONE LEAD AND IT WAS ALSO DETERMINED THAT THE IPG NEEDED TO BE MOVED TO AN AREA ON THE BODY THAT WAS MORE STABLE AND HAD A FLATTER SURFACE AREA TO CORRECT THE CONNECTIVITY ISSUES. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IPG. THE LEADS WERE DISCONNECTED WHILE THE IPG WAS BEING REPOSITIONED. UPON REINSERTING THE LEADS INTO THE IPG, ONE LEAD CONTINUED TO RETURN IMPEDANCE ERRORS ON THE SAME 3 ELECTRODES, HOWEVER THE OTHER 5 ELECTRODES ALSO NOW RETURNED IMPEDANCE ERRORS. TESTING WAS PERFORMED AND CONCLUDED THAT THE LEAD WAS FUNCTIONING AS EXPECTED AND THE LIKELY SOURCE O

  Patient problems: Inadequate Pain Relief

  MAUDE report 23799923 ↗
• InjuryDec 13, 2025Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE MEDIAL BRANCH NERVE NEAR THE L4 VERTEBRAL BODY. AFTER ACTIVATING THE SYSTEM IT WAS NOTED THAT THE LEADS HAD MIGRATED AWAY FROM THE INITIAL PLACEMENT. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS. THE IPG WAS ALSO REPLACED DURING THE PROCEDURE ALTHOUGH THERE WERE NO INDICATIONS OF ANY ISSUE WITH THAT COMPONENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23797636 ↗
• InjuryDec 13, 2025Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. THE FULL SYSTEM WAS REPLACED ON (B)(6) 2024 AFTER EXPERIENCING MIGRATION (SEE MDR 3015425075-2025-00330) AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED AGAIN ON (B)(60 2025 AFTER THE PATIENT EXPERIENCED SIGNIFICANT WEIGHT GAIN. AFTER REPLACING THE IPG THE SECOND TIME ON (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE A GRADUAL CHANGE IN THERAPY THAT WAS CONCLUDED TO BE CAUSED BY MIGRATION OF THE IMPLANTED LEAD 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 IN A SLIGHTLY DIFFERENT LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23797635 ↗
• InjuryDec 8, 2025Impedance Problem; Impedance Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT NOTED THAT THE SYSTEM WAS NO LONGER DELIVERING THERAPY. TESTING OF THE SYSTEM WHILE IMPLANTED FOUND IMPEDANCE ERRORS ON MULTIPLE CONTACTS OF BOTH IMPLANTED LEADS. XRAY IMAGING WAS PERFORMED BUT DID NOT SHOW ANY OBVIOUS ISSUES. ON (B)(6) 2025, A SURGICAL REVISION WAS PERFORMED TO REPLACE THE MALFUNCTIONING SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23740846 ↗
• InjuryDec 8, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM ON (B)(6) 2024 TO TREAT LEFT LOWER EXTREMITY PAIN AND A SECOND PNS SYSTEM WAS IMPLANTED (B)(6) 2025 TO TREAT RIGHT LOWER EXTREMITY PAIN. AFTER IMPLANTING THE SECOND SYSTEM THE PATIENT DEVELOPED A LARGE HEMATOMA AT THE IMPLANT SITE, WHICH CAUSED A DELAY IN ACTIVATION OF THE SYSTEM. WHEN ATTEMPTING TO ACTIVATE, THE SYSTEM RETURNED OPEN CIRCUIT IMPEDANCE READINGS AND WAS UNABLE TO DELIVER THERAPY. TROUBLESHOOTING WAS PERFORMED AND UNABLE TO RESOLVE THE ISSUE. THE PATIENT ULTIMATELY REQUESTED TO REMOVE THE SYSTEM DUE TO THE LACK OF THERAPY. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR EXPLANT OF THE NALU SYSTEM FROM THE RIGHT LOWER EXTREMITY. NO REPRESENTATIVES FROM NALU WERE PRESENT FOR THE EXPLANT PROCEDURE. AFTER THE PROCEDURE TOOK PLACE, THE FIRM WAS NOTIFIED THAT BOTH NALU SYSTEMS HAD BEEN FULLY REMOVED AT THE SAME TIME ON 11/14/2025 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23739130 ↗
• InjuryNov 15, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. UPON ACTIVATING THE SYSTEM, THE PATIENT NOTED THERAPY WAS NOT PROVIDING THE EXPECTED RELIEF TO THE DESIRED AREA OF PAIN. TROUBLESHOOTING IDENTIFIED THAT THE IMPLANTED LEAD HAD MIGRATED FROM THE INITIAL PLACEMENT IN THE VICINITY OF T8-T10 VERTEBRAL BODY TO APPROXIMATELY T7 VERTEBRAL BODY. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED SYSTEM AND PLACE A NEW SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23563545 ↗
• InjuryNov 5, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD 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 THORACIC NERVE AT THE T8-T10 VICINITY. AFTER ACTIVATING THE SYSTEM, THE PATIENT NOTED CHALLENGES WITH MAINTAINING CONSISTENT CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE IPG AND PLACE A NEW ONE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23473187 ↗
• InjuryJul 30, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BILATERAL LOWER BACK PAIN. THE SYSTEM WAS ACTIVATED ON (B)(6) 2025 AND SEVERAL WEEKS LATER THE PATIENT REPORTED HAVING DIFFICULTY MAINTAINING COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. REPROGRAMMING AND TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CORRECT THE PROBLEM. IMAGING WAS PERFORMED BY THE MEDICAL OFFICE AND THE IPG WAS REPORTED TO HAVE MIGRATED BEYOND THE RECOMMENDED DEPTH AS WELL AS ROTATING SO THAT IT WAS NO LONGER SEATED PARALLEL TO THE SKIN SURFACE. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE EXISTING IPG SO THAT IT IS MORE SUPERFICIAL AND POSITIONED PARALLEL TO THE SKIN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22671848 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2025 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) BEING PLACED IN THE LOWER BACK AREA AND LEADS TARGETING THE CLUNEAL NERVE. TWO MONTHS AFTER THE IMPLANT PROCEDURE, THE PATIENT NOTIFIED A NALU REPRESENTATIVE THAT THEY HAD EXPERIENCED FEVER/CHILLS AND NOTED THE IMPLANT INCISION SITE WAS REDDENED. THE PATIENT PRESENTED AT A LOCAL EMERGENCY DEPARTMENT ON THE EVENING OF (B)(6) 2025 AND WAS FOUND TO HAVE DEVELOPED AN ABSCESS UNDER THE INCISION SITE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED HOME WITH ORAL ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 22493902 ↗