Nalu Medical, Inc. 71020 (UDI 00812537037363)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00812537037363), received between Sep 11, 2024 and Sep 21, 2026 — classified as 101 injuries.

The most frequently reported specific device problem is “Intermittent Communication Failure” (30 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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Insufficient Device Problem Information

  Patient problems: Post Operative Wound Infection

  MAUDE report 50846115 ↗
• InjurySep 21, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Insufficient Information

  MAUDE report 50844617 ↗
• InjurySep 13, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50746889 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Erosion

  MAUDE report 50744643 ↗
• InjuryAug 4, 2026Intermittent Communication Failure

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2026 targeting the cluneal nerve. After using the system for some time the patient then reported challenges connecting the Implantable Pulse Generator (IPG) to the external Therapy Discs. Troubleshooting in the field confirmed the external devices to be functioning as expected and found no impedance errors when the system was tested while implanted. Fluoroscopic imaging was completed to rule out IPG migration as a cause of the connectivity issues. Cause of the connectivity issues was unable to be identified so the patient was scheduled for revision of the IPG. On (b)(6) 2026, a surgical procedure was performed to reposition the IPG, however after handling the device it returned impedance errors and required replacement during the same procedure. The implanted leads remained in place and were successfully connected to the new IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50136206 ↗
• InjuryJul 29, 2026Insufficient Device Problem Information

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system targeting the suprascapular nerve on (b)(6) 2026 after participating in a successful trial phase with Nalu. The patient also participated in a wear study with Nalu prior to implanting the permanent system. During the wear study the patient selected a preferred location for the external components, which directs the implant location for the Implantable Pulse Generator (IPG). During the implant procedure on (b)(6) 2026 the patient was positioned on the operating table in a manner that prevented the physician from tunneling to the location chosen for the IPG placement and thus the device was placed in a different location. On (b)(6) 2026, 2 weeks after the implant, the patient contacted a Nalu representative stating that the IPG placement over the collarbone area was causing pain. The patient was instructed to reach out to the implanting physician for follow-up. On (b)(6) 2026, the patient was seen in the medical office. During that visit the patient reported to the Nalu representative that there was a "crunching" sound and pain during arm movement. Additionally, the patient reported lack of pain relief from the

  Patient problems: Pain

  MAUDE report 50076673 ↗
• InjuryJul 27, 2026Intermittent Communication Failure

  On (b)(6) 2026 a surgical procedure was initiated to implant a Nalu Peripheral Nerve Stimulator system. While in the procedure one of the Nalu components intended to be implanted was found to be non-functional. The Implantable Pulse Generator (IPG) was unable to communicate with the clinical programmer device and thus unusable. The malfunction was identified prior to implanting into the patient. A new IPG was introduced and the procedure was able to be successfully completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024550 ↗
• InjuryJul 27, 2026Device Difficult to Setup or Prepare

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2026 targeting the medial branch nerve. The patient had previously participated in a successful trial phase with Nalu. After implanting the system the patient exhibited difficulty in utilizing the external components, requiring multiple re-education sessions regarding how to place the therapy disc over the Implantable Pulse Generator (IPG) and how to charge the therapy disc. The patient repeatedly provided conflicting reports regarding effectiveness of the therapy, resulting in multiple reprogramming sessions with Nalu representatives. The patient ultimately requested to have the system removed, citing potential for MRI needs at some point in the future. As the patient had an existing SCS system in place, the dual systems would prevent MRI scans if needed. At the time of the request there were no known planned MRI needs and the rationale for explant was theoretical. On (b)(6) 2026 a full system explant was performed per patient request.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50024271 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient was implanted with a Nalu Peripheral Nerve Stimulator (PNS) system on (b)(6) 2024 to treat knee pain. At the time of implant a single lead was used to target the genicular nerve. After using the system for approximately 1 year the patient underwent a second trial to determine if adding a second lead would improve therapy in (b)(6) 2025. On (b)(6) 2025 a surgical procedure was performed to add a second permanent lead as well as replace the original Implantable Pulse Generator (IPG). As there are no indications of any system or component failure or malfunction, it is believed that the IPG replacement was a precaution due to the potential for surgical handling damage. The original lead remained in place and was connected to the new IPG. In the beginning of (b)(6) 2026, the patient noted development of discharge at the IPG insertion site, which was reported directly to the implanting physician, and the patient began oral antibiotics. After approximately two weeks the patient was prescribed a different antibiotic medication as the symptoms were not resolving. The plan of care at that time was to follow the prescribed course of antibiotics and if the symptoms were not resolve

  Patient problems: Post Operative Wound Infection

  MAUDE report 50024261 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TARGETING THE SCIATIC NERVE. AFTER USING THE SYSTEM FOR APPROXIMATELY 1 MONTH THE PATIENT REQUESTED A CLINIC VISIT TO ADDRESS CHALLENGES WITH PLACEMENT OF THE EXTERNAL COMPONENTS. DURING THE VISIT, ON (B)(6) 2026, THE NALU REPRESENTATIVE LEARNED THAT THE PATIENT HAD A WOUND AT THE IMPLANT INCISION SITE. THE IMPLANTING PHYSICIAN ASSESSED THE SITE AND DETERMINED THAT THE IMPLANT INCISION SITE HAD DEHISCED AND WAS INFECTED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 25419624 ↗
• InjuryJun 5, 2026Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TARGETING THE LUMBAR MEDIAL BRANCH NERVE. ON (B)(6) 2026 THE FIRM RECEIVED A CALL FROM A VETERAN'S AFFAIRS FACILITY IN (B)(6) AREA TO REQUEST MRI CONDITIONALITY. DURING THE CALL THE FACILITY INFORMED THE NALU PRODUCT SUPPORT REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE A PARTIAL SYSTEM EXPLANT BUT STILL HAD BOTH LEADS REMAINING IMPLANTED. THE FACILITY DID NOT HAVE ANY INFORMATION AS TO REASON FOR THE EXPLANT, DATE IT WAS PERFORMED, OR WHERE IT WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25403449 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TO TREAT KNEE PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED IN THE ANTERIOR THIGH AREA WITH THE LEADS TARGETING THE SUPERIOR GENICULAR NERVE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AT THE TIME OF IMPLANT. THE PATIENT WAS SEEN IN THE CLINIC FOR A POST-OP WOUND CHECK ON (B)(6) 2026 AND THE PHYSICIAN NOTED THE IPG INCISION SITE WAS NOT FULLY CLOSED. THE PHYSICIAN PLACED STERI-STRIPS ON THE SITE AND ASKED PATIENT TO PROVIDE DAILY PICTURES OF THE WOUND STATUS. A DIFFERENT ANTIBIOTIC WAS PRESCRIBED AT THAT TIME. THE INCISION SITE CONTINUED TO NOT HEAL AND ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO ONGOING CONCERNS OF INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24795064 ↗
• InjuryApr 6, 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 EXTREMITY PAIN. AFTER IMPLANTING THE DEVICE, THE PATIENT EXPERIENCED SWELLING AND APPEARANCE OF BLISTERING AT THE IMPLANT SITE. TWO SEPARATE BLOOD CULTURES WERE PERFORMED AND RETURNED NEGATIVE FOR ANY INFECTION. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED WITH THE INTENTION OF REMOVING THE IMPLANTABLE PULSE GENERATOR (IPG) FROM ITS ORIGINAL LOCATION AND RELOCATING TO A NEW POSITION DUE TO ONGOING HEALING ISSUES. UPON OPENING THE SITE TO REMOVE THE IMPLANT THE PHYSICIAN NOTED THE PRESENCE OF A FLUID AT THE SITE. BELIEVING THE FLUID TO BE RELATED TO INFECTION, THE PHYSICIAN ELECTED TO FULLY EXPLANT THE SYSTEM AND ALLOW THE SITE TO HEAL. ALL COMPONENTS WERE FULLY REMOVED WITH NO FRAGMENTS LEFT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24795063 ↗
• InjuryApr 3, 2026Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE NON-TINED SYSTEM AND PLACE A NEW SYSTEM WITH TINED LEADS TO PROVIDE IMPROVED STABILITY AFTER ONE OF THE ORIGINAL LEADS HAD MIGRATED AND CAUSED A REDUCTION OF PAIN RELIEF. SEE MDR 3015425075-2025-00313 AFTER USING THE SYSTEM FOR SEVERAL MONTHS THE PATIENT REPORTED THAT THERAPY WAS STILL NOT MEETING EXPECTATIONS. THE SYSTEM WAS REPROGRAMMED MULTIPLE TIMES TO ATTEMPT OPTIMIZATION OF THERAPY WITH NO SUCCESS. IMAGING AND SYSTEM TESTING RETURNED NO ISSUES. THE PHYSICIAN AND NALU TEAM WERE UNABLE TO IDENTIFY ANY OBVIOUS CAUSE FOR THE LACK OF PAIN RELIEF AND THUS A FULL SYSTEM REPLACEMENT WAS PERFORMED ON (B)(6) 2026. THE EXPLANTED SYSTEM WAS NOT RELEASED BY THE FACILITY FOR FURTHER INVESTIGATION BY NALU.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24776529 ↗
• InjuryApr 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 BACK PAIN. THE INCISION SITE FAILED TO PROPERLY HEAL WITHIN THE EXPECTED TIMEFRAME, CAUSING A DELAY IN ACTIVATING THE SYSTEM. WHEN APPROVED, THE SYSTEM WAS ACTIVATED FOR A SHORT TIME BEFORE THE INCISION SITE AGAIN DISPLAYED SIGNS OF POOR HEALING. AFTER A LENGTHY STRUGGLE WITH AN OPEN INCISION SITE, THE PATIENT ALSO DEVELOPED INFECTION AT THE SITE AND THE PHYSICIAN ADVISED REMOVAL. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO ONGOING HEALING ISSUES AS WELL AS PRESENCE OF INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24761459 ↗
• InjuryApr 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. APPROXIMATELY 1 MONTH AFTER THE IMPLANT THE SYSTEM WAS DISCOVERED TO HAVE OPEN CIRCUIT READINGS DUE TO A FRACTURE OF THE LATERAL LEAD. ON (B)(6) 2025 THE FRACTURED LEAD WAS REPLACED. AFTER REPLACING THE LEAD, THE PATIENT EXPERIENCED CHALLENGES IN WOUND HEALING AT THE SURGICAL SITE, INCLUDING SKIN EROSION AROUND THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). ON (B)(6) 2025 THE IMPLANTED COMPONENTS WERE REMOVED AND NEW COMPONENTS WERE PLACED IN A DIFFERENT LOCATION. THE NEW IMPLANT SITE APPEARED TO HAVE BEEN HEALING WELL, HOWEVER AT THE 3 MONTH POST-OP VISIT ON (B)(6) 2025 THE MEDICAL TEAM DISCOVERED THAT THE NEW SURGICAL SITE THAT HAD BEEN HEALING HAD THEN DEHISCED AND WAS SHOWING SIGNS OF POSSIBLE INFECTION. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND ON (B)(6) 2026 THE NALU SYSTEM WAS FULLY REMOVED.

  Patient problems: Wound Dehiscence

  MAUDE report 24754287 ↗
• InjuryMar 30, 2026Intermittent Communication Failure

  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 LUMBAR NERVE. UPON ACTIVATION OF THE SYSTEM, IT WAS NOTED THAT MAINTAINING CONNECTIVITY BETWEEN THE IPG AND EXTERNAL THERAPY DISCS WAS VERY CHALLENGING. ASSESSMENT FOUND THE IPG DIFFICULT TO PALPATE, POINTING TOWARD A POTENTIAL MIGRATION ISSUE. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IPG. UPON OPENING THE SITE, THE IPG WAS OBSERVED TO HAVE ROTATED WITHIN THE POCKET TO NO LONGER BE FLAT AND PARALLEL TO THE SKIN SURFACE, WHICH CAUSED THE CONNECTIVITY CHALLENGES. THE ORIGINAL IPG WAS REPOSITIONED INTO A NEW POCKET TO BE FLAT AND SUPERFICIAL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24736892 ↗
• InjuryMar 25, 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 FOOT PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE CALF AREA WITH THE LEADS TARGETING THE DEEP PERONEAL AND TIBIAL NERVES. IN (B)(6) 2026 THE PATIENT REACHED OUT TO A NALU REPRESENTATIVE TO NOTIFY THAT AN INFECTION HAD DEVELOPED AT THE IMPLANT SITE AND THERE WAS A POSSIBILITY OF EXPLANT. THE PATIENT REPORTED THAT THE SURGICAL INCISION HAD NEVER FULLY HEALED AND HAD DEVELOPED PAIN AND SWELLING. THE PATIENT NOTED THAT THE PHYSICIAN WAS AWARE OF THE CONDITION AND WAS TREATING THE WOUND, HOWEVER THE EXPLANT WAS BEING DELAYED TO CONFIRM PATIENT WAS MEDICALLY STABLE FOR THE PROCEDURE. ON (B)(6) 2026 THE PATIENT REPORTED THAT A FULL SYSTEM EXPLANT HAD BEEN PERFORMED ON (B)(6) 2026 DUE TO THE ONGOING COMPLICATIONS WITH THE INCISION SITE AND INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24683856 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT BACK PAIN. SEVERAL MONTHS AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED DISCOMFORT FROM OVERSTIMULATION. THE PATIENT WAS SEEN MULTIPLE TIMES FOR REPROGRAMMING OVER THE SUBSEQUENT YEAR, HOWEVER THE PATIENT CONTINUED TO EXPRESS DISSATISFACTION WITH THERAPY. ON (B)(6) 2026 A SYSTEM EXPLANT WAS ATTEMPTED AT THE REQUEST OF THE PATIENT. DURING THE PROCEDURE THE PHYSICIAN FOUND THAT BOTH LEADS HAD SIGNIFICANT SCARRING AND WERE UNABLE TO BE REMOVED DESPITE HYDRODISECTION BEING USED TO LOOSEN THE COMPONENTS. BOTH LEADS FRACTURED AND WERE THUS LEFT IN PLACE WITH INSTRUCTIONS FOR THE PATIENT TO SEEK SURGICAL CONSULT IF THEY WISH TO REMOVE THE LEAD FRAGMENT IN THE FUTURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUCCESSFULLY REMOVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24683614 ↗
• InjuryMar 9, 2026Improper or Incorrect Procedure or Method

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TARGET THE SCIATIC NERVE. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED ONGOING ISSUES WITH MAINTAINING THE EXTERNAL DEVICES. SPECIFICALLY, THE ADHESIVE CLIPS USED TO HOLD THE THERAPY DISCS IN PLACE OVER THE IMPLANT WERE NOT STAYING ADHERED TO THE SKIN AND ALLOWING THE THERAPY DISCS TO FALL OFF. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE AND ULTIMATELY IT WAS FOUND THAT THE SUPERFICIAL PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR WAS CAUSING THE IMPLANT TO PRESS AGAINST THE UNDERSIDE OF THE SKIN AND SIT PROUD ABOVE THE NORMAL SKIN SURFACE. THE PROTRUDING DEVICE WAS CAUSING AN UNEVEN SURFACE FOR THE ADHESIVE CLIPS, WHICH LED TO ADHESIVE CLIP FAILURE AND LOSS OF THERAPY. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO MOVE THE EXISTING IPG TO A SLIGHTLY DEEPER POSITION SO THAT THERE WAS NO PRESSURE UPWARD AGAINST THE SKIN SURFACE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24554248 ↗
• InjuryMar 9, 2026Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TARGET THE SCIATIC NERVE. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED ONGOING ISSUES WITH MAINTAINING THE EXTERNAL DEVICES. SPECIFICALLY, THE ADHESIVE CLIPS USED TO HOLD THE THERAPY DISCS IN PLACE OVER THE IMPLANT WERE NOT STAYING ADHERED TO THE SKIN AND ALLOWING THE THERAPY DISCS TO FALL OFF. TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE AND ULTIMATELY IT WAS FOUND THAT THE SUPERFICIAL PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR WAS CAUSING THE IMPLANT TO PRESS AGAINST THE UNDERSIDE OF THE SKIN AND SIT PROUD ABOVE THE NORMAL SKIN SURFACE. THE PROTRUDING DEVICE WAS CAUSING AN UNEVEN SURFACE FOR THE ADHESIVE CLIPS, WHICH LED TO ADHESIVE CLIP FAILURE. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO MOVE THE EXISTING IPG TO A SLIGHTLY DEEPER POSITION SO THAT THERE WAS NO PRESSURE UPWARD AGAINST THE SKIN SURFACE. ON (B)(6) 2026 THE PATIENT REACHED OUT TO A NALU REPRESENTATIVE TO INFORM THAT THE INCISION SITE HAD BECOME SWOLLEN AND THE PATIENT HAD GONE TO THE LOCAL EMERGENCY DEPARTMENT FOR EVALUATION. AFTER SPEAKING WITH THE PHYSICIAN ASSISTANT AT THE ACUTE FACILITY, IT WAS DISCOVER

  Patient problems: Hematoma

  MAUDE report 24554247 ↗
• 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. WITHIN SERVERAL WEEKS OF THE IMPLANT, THE PATIENT BEGAN TO EXIBIT SIGNS OF INFECTION. ANTIBIOTICS WERE PRESCRIBED BUT DID NOT ELIMINATE THE SYMPTOMS. THE SITE WAS ASSESSED DURING A CLINIC VISIT AND DIAGNOSIS WAS BASED ON VISUALIZATION OF THE WOUND. THE PATIENT DID NOT ATTEND THE FOLLOW-UP APPOINTMENTS AND THUS FURTHER ASSESSMENTS WERE CONDUCTED VIA PHONE CALLS BETWEEN THE PATIENT AND PHYSICIAN. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO ONGOING AND UNRESOLVED SYMPTOMS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24554246 ↗
• InjuryMar 7, 2026Intermittent Communication Failure

  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 REPORTED CHALLENGES WITH MAINTAINING CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. SPECIFICALLY, THE PATIENT NOTED CONNECTIVITY WAS ACHIEVED ONLY IN CERTAIN POSITIONS AND WOULD DISCONNECT UPON CHANGING POSITIONS. ASSESSMENT IN THE FIELD DETERMINED THAT THE IPG WAS TILTING OR ROLLING WITH THE SURROUNDING TISSUE IN THE MYOFASCIAL PLANE AS THE PATIENT MOVED. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE EXISTING IPG AND REPOSITION IT TO A DIFFERENT ORIENTATION TO AVOID ANY SHIFTING WITH PATIENT MOVEMENT. THE PATIENT REPORTED RESOLUTION OF SYMPTOMS AFTER THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24541138 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM TO TREAT KNEE PAIN. ON 01/20/2026 THE PATIENT NOTIFIED A NALU REPRESENTATIVE THAT A BUBBLE HAD FORMED AT THE INCISION SITE AND AFTER THE PATIENT EXPRESSED LIQUID FROM THE SITE, THE IMPLANTED LEAD WAS THEN EXPOSED AND PROTRUDING THROUGH THE SKIN. PATIENT WAS ADVISED TO SEEK MEDICAL TREATMENT. IMPLANTING PHYSICIAN ADVISED THE PATIENT TO GO TO THE LOCAL ACUTE FACILITY FOR EXPLANT. ON (B)(6) 2026 A FULL SYSTEM EXPLANT TOOK PLACE. LAB CULTURES RETURNED POSITIVE FOR SERRATIA BACTERIA. THE PATIENT WAS DISCHARGED HOME WITH A PIC LINE FOR ADMINISTRATION OF ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24474840 ↗
• InjuryFeb 27, 2026Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER EXTREMITY PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT NOTED CHALLENGES WITH CONNECTIVITY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. ASSESSMENT OF THE SYSTEM FOUND THAT THE IPG HAD MIGRATED PAST THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE IPG TO A MORE SUPERFICIAL POSITION. DURING THE PROCEDURE THE IPG FAILED TESTING, LIKELY DUE TO SURGICAL HANDLING DAMAGE, AND WAS REPLACED. IMPLANTED LEADS WERE NOT REPLACED AND REMAIN IN USE WITH THE NEW IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24474834 ↗