Nalu Medical, Inc. 71020-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00812537036182), received between Jan 5, 2022 and Sep 28, 2026 — classified as 213 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (27 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 213 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Rash; Unspecified Tissue Injury

  MAUDE report 50926001 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  The Nalu Representative (rep) reported that the patient is suspected of having an infection at the incision site. The patient was prescribed antibiotics and planned to follow up with the physician at the surgical facility. Follow up found that the patient is reported as having the incision healed, open to air, and has resumed therapy.

  Patient problems: Wound Infection

  MAUDE report 50900578 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wound Infection

  MAUDE report 50889580 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  The Nalu Sales Representative (rep) reported that the patient called and stated that he was working and he had a massive back spasm in his work truck, and he went home from work. The patient called the next day and stated that he went to the ER, had a CT scan, and it was unremarkable. The patient stated that these spasms happen when the disc is both providing therapy and is off his body as well. The patient has been seen by the implanting physician subsequent to the spasm episode and it was noted that the spasm subsided with no intervention and was instructed to reach out to Nalu if he needed any adjustments to his therapy. There was no reported patient harm or injury.

  Patient problems: Back pain

  MAUDE report 50871705 ↗
• InjurySep 18, 2026Patient-Device Incompatibility

  Patient problems: Erosion; Foreign Body In Patient

  MAUDE report 50828622 ↗
• InjuryJul 27, 2026Intermittent Communication Failure

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2023, targeting bilateral cluneal nerves. In (b)(6) 2024 the patient received replacements for external therapy discs due to challenges in maintaining connection between the therapy discs and the Implantable Pulse Generator (IPG). Loss of connectivity results in disruption of therapy. In (b)(6) 2026 the patient underwent surgical revision to correct connectivity issues. On (b)(6) 2026, during the surgical procedure, the IPG displayed only sporadic connectivity with a Clinician Programmer device as well as the patient's therapy discs. A new IPG was introduced and connected to the existing implanted leads. Intra-operative testing confirmed all good impedances and connectivity with the new IPG and the procedure was successfully completed.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50024551 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023, TARGETING THE RIGHT AXILLARY NERVE. IN (B)(6) 2026 THE PATIENT REQUESTED TO REMOVE THE NALU SYSTEM SO THAT A FULLY BODY MRI COULD BE PERFORMED DUE TO A NEW CANCER DIAGNOSIS. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419623 ↗
• InjuryJun 1, 2026Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TARGETING THE COCCYGEAL NERVE. APPROXIMATELY 7 WEEKS AFTER THE IMPLANT PROCEDURE, ON 08/29/2024, THE PATIENT REPORTED THAT ONE OF THE EXTERNAL THERAPY DISCS WOULD NOT CONNECT TO THE IMPLANTABLE PULSE GENERATOR (IPG). FIELD TROUBLESHOOTING FOUND THAT THE DISC WAS FUNCTIONING WELL AND SUSPICION AT THAT POINT WAS IPG POSITIONING. AFTER ALLOWING ADDITIONAL TIME FOR THE IMPLANT SITE SWELLING TO REDUCE AND EDUCATING THE PATIENT ON THERAPY DISC PLACEMENT, THE CONNECTIVITY ISSUES APPEARED TO HAVE BEEN RESOLVED. IN (B)(6) 2025 THE PATIENT ASSERTED THAT NO FURTHER INTERVENTION WOULD BE REQUIRED. THE PATIENT USED THE SYSERM FOR MORE THAN A YEAR BEFORE AGAIN REPORTING IN (B)(6) 2026 TO THE MEDICAL PROVIDER THAT THE CONNECTIVITY CHALLENGES WERE PERSISTING AND THE PATIENT WANTED TO PURSUE IPG REVISION. ON (B)(6) 2026 THE EXISTING IPG WAS REMOVED FROM THE ORIGINAL POCKET LOCATION AT THE LOWER BACK AREA AND RELOCATED TO THE ABDOMINAL AREA TO ALLOW EASIER ACCESS FOR EXTERNAL DEVICE PLACEMENT. A LEAD EXTENSION WAS ADDED TO ACCOMODATE THE NEW POSITION OF THE IPG. IMAGING PERFORMED AFTER RELOCATION CONFIRMED THE IP

  Patient problems: Inadequate Pain Relief

  MAUDE report 25356549 ↗
• InjuryJun 1, 2026Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT KNEE PAIN. ON (B)(6) 2025 THE FIRM WAS CONTACTED BY AN MRI FACILITY TO REQUEST INFORMATION ON SYSTEM MRI CONDITIONALITY. THE FACILITY WAS ADVISED THAT THE SYSTEM WAS CONDITIONAL FOR THE SPECIFIED SCAN AREA. THE FIRM PROVIDED AN MRI CHECKLIST, INCLUDING INFORMATION AS TO IMPLANTED COMPONENTS AND REQUIREMENT TO PERFORM IMPEDANCE CHECK WITHIN 7 DAYS OF THE SCAN. NO FURTHER FEEDBACK WAS RECEIVED AT THAT TIME. ON (B)(6) 2026 THE FIRM WAS AGAIN CONTACTED BY AN MRI FACILITY TO REQUEST INFORMATION ON MRI CONDITIONALITY. DURING THAT COMMUNICATION THE MRI FACILITY REPORTED THAT, PER THE PATIENT, A PARTIAL SYSTEM EXPLANT HAD BEEN PERFORMED WITH ALL OR PART OF THE LEADS HAVING BEEN ABANDONED AND REMAINING IMPLANTED. UPON REACHING OUT TO THE MEDICAL PROVIDER, THE FIRM LEARNED THAT THE EXPLANT HAD BEEN PERFORMED ON (B)(6) 2026. THE PROVIDER REPORTED THAT THE SYSTEM HAD FAILED THE IMPEDANCE CHECK AND THUS PREVENTED AN MRI FROM BEING PERFORMED. THE PATIENT REPORTEDLY HAD NOT BEEN USING THE SYSTEM FOR SOME TIME AND CHOSE TO EXPLANT RATHER THAN REVISE TO CORRECT THE IMPEDANCE. THE EXPLANT WAS PERFORMED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356548 ↗
• InjuryNov 15, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE PATIENT DID NOT PARTICIPATE IN A TRIAL PHASE WITH NALU AS THE SYSTEM WAS IMPLANTED TO REPLACE AN EXISTING NEUROSTIMULATOR SYSTEM FROM A DIFFERENT MANUFACTURER. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE CLUNEAL NERVES. AFTER ACTIVATING THE SYSTEM, THE PATIENT IS REPORTED TO HAVE HAD ONGOING CONNECTIVITY CHALLENGES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, HOWEVER INDICATION FROM NALU REPRESENTATIVES WAS THAT THE PATIENT WAS ABLE TO ACHIEVE GOOD THERAPY DESPITE THE CONNECTIVITY ISSUES. IN (B)(6) 2025 THE PATIENT PROVIDED A PHOTOGRAPH OF BOTH EXTERNAL THERAPY DISCS WITH THE POWER BUTTON COVERS COMPLETELY MISSING. SINCE THE DEVICES FELL OUTSIDE OF THE WARRANTY PERIOD, THE PATIENT ELECTED TO NOT REPLACE THEM AND TO INSTEAD PURSUE EXPLANT OF THE NALU SYSTEM. NALU PERSONNEL ATTEMPTED TO CONTACT THE PATIENT ON MULTIPLE OCCASIONS AND REPORT THAT THE PATIENT HAS DECLINED TO SPEAK WITH THEM OR PROVIDE ANY FURTHER INFORMATION. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23563544 ↗
• InjuryNov 5, 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) 2022 TO TREAT UPPER EXTREMITY PAIN. APPROXIMATELY 3 YEARS AFTER IMPLANTING THE SYSTEM THE IMPLANTABLE PULSE GENERATOR (IPG) BEGAN TO ERODE THROUGH THE SKIN. ON (B)(6) 2025 THE IPG WAS REMOVED DUE TO THE EROSION. THE IMPLANTED LEADS WERE LEFT IN PLACE WITH NO REPORTS OF ANY PLANS FOR FURTHER INTERVENTION AT THIS TIME.

  Patient problems: Skin Erosion

  MAUDE report 23473183 ↗
• InjuryAug 23, 2025Use of Device Problem; Use of Device Problem

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2025 TO TREAT SHOULDER PAIN. THE PATIENT HAD PARTICIPATED IN A SUCCESSFUL TRIAL PHASE WITH NALU AS WELL AS A WEAR STUDY PRIOR TO IMPLANTING THE PERMANENT SYSTEM. THE PATIENT CHOSE A LOCATION ON THE FRONT CLAVICLE AREA TO PLACE THE IMPLANTABLE PULSE GENERATOR (IPG) WITH THE LEADS PLANNING TO TARGET BILATERAL SUPRASCAPULAR NERVES. PRIOR TO THE IMPLANT PROCEDURE, THE PHYSICIAN AND NALU REPRESENTATIVE PERFORMED MEASUREMENTS AND THE PHYSICIAN DETERMINED THAT 40CM LEADS WOULD BE USED. UPON BEGINING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE CHOSEN 40CM LEADS WERE NOT SUFFICIENT TO REACH FROM THE NERVE TARGET TO THE PATIENT'S CHOSEN IPG LOCATION. THE PHYSICIAN CONSULTED WITH THE PATIENT'S SPOUSE AND PLACED THE IPG IN THE POSTERIOR SHOULDER AREA INSTEAD OF THE FRONT OF THE SHOULDER. THE PATIENT REPORTED DISSATISFACTION WITH THE LOCATION OF THE IPG AND REQUESTED TO REVISE THE SYSTEM TO PLACE THE IPG AT THE ORIGINAL REQUESTED LOCATION. ON (B)(6) 2025 THE IPG WAS REMOVED FROM THE POSTERIOR SHOULDER AND PLACED IN THE ANTERIOR CLAVICLE AREA. LEAD EXTENSIONS WERE INTRODUCED TO ACCOMODATE THE NEW IPG LOCATION. NO COMPONENTS W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881256 ↗
• InjuryAug 23, 2025Lack of Effect; Lack of Effect

  THE PATIENT PARTICIPATED IN A TRIAL PHASE WITH NALU BEFORE BEING IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT FOOT PAIN. DURING THE TRIAL PHASE THE PATIENT HAD NOTED THAT THE PLACEMENT OF THE LEADS DID NOT COVER THE ENTIRE FOOT, HOWEVER CHOSE TO MOVE FORWARD WITH THE PERMANENT IMPLANT AS THE AMOUNT OF COVERAGE BEING RECIEVED WAS SATISFACTORY FOR THE PATIENT. THE PERMANENT SYSTEM WAS IMPLANTED USING BOTH ULTRASOUND AND FLUOROSCOPY TO ASSURE APPROPRIATE PLACEMENT. THE SYSTEM WAS ACTIVATED ON (B)(6) 2024 AND A FOLLOW-UP PROGRAMMING SESSION WAS PERFORMED ON (B)(6) 2024. DURING THE FOLLOW-UP SESSION THE PATIET REPORTED REDUCTION IN PAIN SYMPTOMS FROM 8/10 DOWN TO 3/10. IN (B)(6) 2025 THE MEDICAL OFFICE NOTIFIED A NALU REPRESENTATIVE THAT THE PATIENT WAS REQUESTING TO REMOVE THE NALU SYSTEM DUE TO LACK OF SUFFICIENT PAIN RELIEF. THE PATIENT HAD BEEN SEEN MULTIPLE TIMES OVER THE COURSE OF THE YEAR THAT THE SYSTEM WAS IMPLANTED AND MULTIPLE REPROGRAMMING SESSIONS HAD BEEN PERFORMED TO IMPROVE THERAPY AND COVERAGE, HOWEVER THE PATIENT ULTIMATELY DECIDED THAT COVERAGE WAS INSUFFICIENT. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881254 ↗
• InjuryAug 19, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2023 TARGETING THE MEDIAL BRANCH NERVE TO TREAT NECK PAIN. IN AUGUST 2025 THE MEDICAL CLINIC NOTIFIED A NALU REPRESENTATIVE THAT THE PATIENT WAS SCHEDULED FOR A BRAIN MRI AND WOULD NEED TO HAVE THE NALU SYSTEM REMOVED SO THAT THE SCAN COULD TAKE PLACE. AN EXPLANT PROCEDURE WAS INITIATED ON (B)(6) 2025 AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUCCESSFULLY REMOVED. THE PHYSICIAN DISSECTED DOWN THE LEADS TO THE LOCATION OF THE TINED PORTION BEFORE ABORTING THE PROCESS. PHYSICIAN NOTED BEING UNCOMFORTABLE PROCEDING ANY FURTHER WITH REMOVAL OF THE LEADS AND CLOSED THE PROCEDURE WITH THE LEADS REMAINING IN PLACE. THE PATIENT IS CURRENTLY UNABLE TO MOVE FORWARD WITH THE MRI WITH THE LEADS REMAINING IMPLANTED. PATIENT HAS REPORTED THAT THEY WILL REACH OUT TO THE OTHER DOCTOR TO EXPLORE OTHER DIAGNOSTIC OPTIONS. IF THE MRI IS STILL REQUIRED, THEN THE PATIENT WILL BE REFERRED TO A DIFFERENT SURGEON TO REMOVE THE REMAINING LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846491 ↗
• InjuryAug 10, 2025Fracture; Device Unsafe to Use in Environment; Fracture; Device Unsafe to Use in Environment

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT SHOULDER PAIN. IN (B)(6) 2024 AND AGAIN IN (B)(6) 2025 THE FIRM RECEIVED REQUESTS FOR MRI CONDITIONALITY. PATIENT'S SYSTEM IS NOT CLEARED FOR MRI AND THUS THE PATIENT ELECTED TO REMOVE THE SYSTEM. ON (B)(6) 2025 AN EXPLANT WAS PERFORMED; HOWEVER, THE IMPLANTED LEADS FRACTURED DURING THE PROCEDURE AND THE PHYSICIAN WAS UNABLE TO FULLY REMOVE THE REMAINING FRAGMENTS. THE PATIENT IS BEING REFERRED TO AN ORTHOPEDIC SURGEON TO COMPLETE THE EXPLANT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768325 ↗
• InjuryAug 5, 2025Device Unsafe to Use in Environment; Intermittent Communication Failure; Lack of Effect; Device Unsafe to Use in Environment; Intermittent Communication Failure; Lack of Effect

  ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM TO TREAT LEFT SHOULDER PAIN. AFTER HAVING THE SYSTEM IMPLANTED, THE PATIENT EXPRESSED FRUSTRATION REGARDING MRI RESTRICTIONS BUT DID NOT REPORT ANY OTHER ISSUES OR CONCERNS WITH THE NALU SYSTEM OR ITS COMPONENTS. ON (B)(6) 2025 THE PATIENT REACHED OUT TO A LOCAL NALU REPRESENTATIVE TO DISCUSS MRI CONDITIONALITY. DURING THE CONVERSATION ON (B)(6) 2025, THE PATIENT REPORTED THAT THE NALU SYSTEM HAD BEEN EXPLANTED ON (B)(6) 2025. NALU PERSONNEL HAD NOT RECEIVED ANY NOTIFICATION OF THE EXPLANT PRIOR TO PATIENT NOTIFICATION ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT REACHED OUT TO NALU PRODUCT SUPPORT FOR ADDITIONAL MRI CONDITIONALITY INFORMATION AND REPORTED THAT AT THE TIME OF EXPLANT THE PHYSICIAN WAS UNABLE TO FULLY REMOVED THE TINED END OF THE IMPLANTED LEAD AND CUT THE END OFF, LEAVING THE DISTAL END OF THE LEAD IMPLANTED. DURING THE PRODUCT SUPPORT CALL, THE PATIENT ALSO ALLEGED THAT THERAPY HAD BEEN INEFFECTIVE AND THAT THERE WERE CHALLENGES USING THE EXTERNAL WEARABLES WHICH ALSO AFFECTED DELIVERY OF THERAPY FROM THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723532 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A NALU PERIPHERAL NERVE STIMULATOR WAS IMPLANTED ON (B)(6) 2024 TO TREAT HIP PAIN. IN (B)(6) 2024 THE PATIENT IS RECORDED TO HAVE REPORTED REDUCTION IN PAIN LEVELS FROM 8/10 DOWN TO 1/10. ON (B)(6) 2025 THE PATIENT REPORTED THAT THE SYSTEM IS NO LONGER PROVIDING RELIEF AND REQUESTED TO HAVE IT REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 AS REQUESTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22391741 ↗
• InjuryJun 27, 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) 2024 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) PLACED IN THE ANTERIOR THIGH AREA. ON (B)(6) 2024 A REVISION PROCEDURE WAS PERFORMED TO MOVE THE EXISTING IPG TO A MORE SUPERFICIAL LOCATION TO IMPROVE COMMUNICATION. NO COMPONENTS WERE REPLACED DURING THE PROCEDURE AND ALL ORIGINAL COMPONENTS REMAIN IMPLANTED AND IN USE (SEE INCIDENT 3549). AFTER THE REVISION PROCEDURE, THE PATIENT HAD REPORTED NO FURTHER COMPLAINTS OR ISSUES UNTIL AFTER HAVING A PACEMAKER IMPLANTED. DATE OF THE PACEMAKER IMPLANT IS UNKNOWN. DURING THE HEALING PROCESS AFTER PACEMAKER IMPLANT, THE PATIENT WAS UNABLE TO SHOWER AND THUS DEVELOPED A LOCALIZED SKIN INFECTION AT THE SITE OF THE ADHESIVE NALU CLIP. PATIENT WAS PLACED ON ANTIBIOTICS, WHICH WERE NOT SUCCESSFUL IN CLEARING THE SUSPECTED INFECTION. LATER ASSESSMENT BY THE PHYSICIAN FOUND THAT THE SYMPTOMS WERE PROGRESSING AND IT WAS SUSPECTED THAT THE NALU IMPLANT WAS BECOMING INVOLVED AND REQUIRED EXPLANT. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 DUE TO EXPANDING SYMPTOMS FROM SUSPECTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22343160 ↗
• InjuryJun 4, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE IMPLANTED LEADS TARGETING THE CLUNEAL NERVE. SHORTLY AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED FEELING A POP SENSATION NEAR THE IMPLANT SITE AND SUBSEQUENTLY HAD PAIN AT THE SITE REGARDLESS IF THE SYSTEM WAS ACTIVATED OR NOT. A FULL SYSTEM REPLACEMENT WAS PERFORMED ON (B)(6) 2024. THE NEW IPG WAS PLACED BACK IN THE SAME POCKET AND THE LEADS ARE TARGETING THE SAME NERVE LOCATION. SEE MDR 3015425075-2024-00299. APPROXIMATELY ONE MONTH AFTER REPLACING THE SYSTEM IN (B)(6) 2024, THE PATIENT NOTED SOME COMMUNICATION ISSUES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. THE PATIENT WAS SEEN FOR MULTIPLE REPROGRAMMING AND TROUBLESHOOTING SESSIONS AND ULTIMATELY WAS UNABLE TO ACHIEVE ADEQUATE THERAPY, LEADING TO A REQUEST FOR DEVICE REMOVAL. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22147195 ↗
• InjuryMay 22, 2025Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT RIGHT LOWER EXTREMITY PAIN. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR AN MRI SCAN. DURING THE SCAN, THE PATIENT EXPERIENCED SOME HEATING SENSATION AND THE EXTREMITY WHERE THE NALU DEVICE WAS IMPLANTED HAD SOME INVOLUNTARY MOVEMENT. THE SCAN WAS STOPPED UPON EXPERIENCING THOSE SENSATIONS AND THE MRI FACILITY REPORTED NO HARM TO THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 22067394 ↗
• InjuryMay 14, 2025Intermittent Communication Failure; Intermittent 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 IMPLANTED LEADS TARGETING THE CLUNEAL NERVE. WITHIN 2 WEEKS OF IMPLANT, THE PATIENT REPORTED SOME ISSUES WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. ONE OF THE THERAPY DISCS APPEARED TO HAVE MORE ISSUES THAN THE OTHER AND WAS REPLACED IN (B)(6) 2025, HOWEVER THE COMMUNICATION ISSUES PERSISTED. ULTIMATELY IT WAS DETERMINED THAT THE IPG HAD MIGRATED WITHIN THE POCKET TO NO LONGER BE SITTING PARALLEL TO THE SKIN SURFACE, CAUSING THE COMMUNICATION ISSUES. THE PATIENT ALSO NOTED THAT ONE OF THE IMPLANTED LEADS DID NOT APPEAR TO BE PROVIDING THE SAME COVERAGE AS WAS EXPERIENCED DURING THE TRIAL. VERY SLIGHT MIGRATION WAS NOTED AT THE RIGHT LEAD, SO THE PATIENT WAS STILL RECEIVING THERAPY FROM THE LEAD BUT NOT AS EFFECTIVE AS EXPECTED. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MIGRATED IPG AND PLACE A NEW ONE INTO THE SAME POCKET LOCATION BUT SEATED PARALLEL TO THE SKIN SURFACE. BOTH IMPLANTED LEADS WERE REPLACED DURING THE PROCEDURE AS WELL AS A PRECAUT

  Patient problems: Inadequate Pain Relief

  MAUDE report 22021168 ↗
• InjuryMay 7, 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 UPPER LEG PAIN. ON (04/09/2025, THE FIRM WAS NOTIFIED THAT THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT ON (B)(6) 2024, LESS THAN 30 DAYS AFTER THE IMPLANT. NOTIFICATION CAME THROUGH A PHONE CALL FROM AN ENDEAVOR HEALTH MRI TECHNICIAN TO THE NALU PRODUCT SUPPORT TEAM. THE MRI TECHNICIAN (NAME UNKNOWN) NOTIFIED NALU PRODUCT SUPPORT THAT THE SYSTEM HAD BEEN EXPLANTED BY THE SAME PHYSICIAN WHO DID THE IMPLANT. PRODUCT SUPPORT REACHED OUT TO THE PATIENT FOR FOLLOW UP AND NO REPLY HAS BEEN RECEIVED. NALU FIELD SUPPORT PERSONNEL HAVE REACHED OUT TO THE PHYSICIAN'S OFFICE FOR FOLLOW-UP AND HAVE NOT RECEIVED A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21982148 ↗
• InjuryMay 7, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM. ON (B)(6) 2024 THE PATIENT DEVELOPED SYMPTOMS OF INFECTION AT THE INCISION SITE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 DUE TO SUSPECTED INFECTION. LAB CULTURES TAKEN DURING EXPLANT CONFIRMED PRESENCE OF INFECTION, TYPE AND SOURCE ARE UNKNOWN TO THE FIRM. SEE MDR 3015425075-2024-00117. THE PATIENT WAS RE-IMPLANTED WITH A NALU PNS SYSTEM ON (B)(6) 2024 IN THE SAME LOCATION AS THE ORIGINAL IMPLANT. IN (B)(6) 2025 THE PATIENT REQUESTED EXPLANT OF THE SYSTEM IN ORDER TO GET A 3T MRI SCAN OF THE TORSO. THE PHYSICIAN DISCUSSED THE ABILITY TO GET A 1.5T MRI OR A CT SCAN WITH THE NALU SYSTEM IN PLACE. THE PATIENT MAINTAINED THE DECISION TO MOVE FORWARD WITH REMOVAL OF THE NALU SYSTEM DESPITE REPORTS OF GOOD PAIN RELIEF. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982147 ↗
• InjuryMay 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH BILATERAL LEAD PLACEMENT TARGETING THE OCCIPITAL NERVE TO TREAT HEAD AND NECK PAIN. AFTER IMPLANTING THE SYSTEM, ONE OF THE INCISION SITES FAILED TO HEAL PROPERLY AND THE SURGICAL WOUND DEHISCED. ON (B)(6) 2024 THE PATIENT WAS BROUGHT IN TO THE OPERATING ROOM AND PLACED UNDER ANESTHESIA FOR A SURGICAL DEBRIDEMENT. AT THAT TIME THE 25CM LEAD WAS BURIED DEEPER AS WELL AND THE SURGICAL WOUND WAS CLOSED. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE INTRODUCED. THE PATIENT WAS ADVISED TO NOT USE THE NALU SYSTEM UNTIL THE SURGICAL SITE WAS COMPLETELY HEALED. ON (B)(6) 2025 THE PATIENT WAS SEEN IN THE PHYSICIAN'S CLINIC FOR COMPLAINTS OF SORENESS AT THE IMPLANT SITE. UPON EXAMINATION THE PATIENT WAS FOUND TO HAVE THE IMPLANTED LEAD EXPOSED THROUGH THE SKIN. A LAB CULTURE WAS TAKEN TO DETERMINE IF INFECTION WAS PRESENT, HOWEVER THE RESULTS ARE NOT AVAILABLE TO THE FIRM FOR CONFIRMATION. ON (B)(6) 2025 THE PATIENT WAS BROUGHT IN TO THE OPERATING ROOM AND PLACED UNDER ANESTHESIA

  Patient problems: Wound Dehiscence

  MAUDE report 21956700 ↗
• InjuryMar 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023. IN (B)(6) 2023 THE PATIENT REPORTED TO THE PHYSICIAN THAT ONE OF THE IMPLANTED LEADS WAS EXPOSED THROUGH THE SKIN AT THE SURGICAL INCISION SITE. ON (B)(6)2023 THE INCISION WAS OPENED AND THE LEAD WAS PLACED BACK INTO A DEEPER POSITION. DURING THE PROCEDURE THE SITE WAS WASHED AND PACKED WITH ANTIBIOTIC BEFORE RE-CLOSING. THERE WERE NO INDICATIONS OF INFECTION BASED ON VISUAL ASSESSMENT AND NO LAB TEST WERE DONE TO DETERMINE PRESENCE OF INFECTION AT THE SITE. THERE WERE NO REPORTS OF TRAUMA OR OTHER EXTERNAL FACTORS THAT WOULD LEAD TO THE INCIDENT. ALL IMPLANTED COMPONENTS REMAINED IMPLANTED AND IN USE AND THE SITE APPEARED TO HAVE FULLY HEALED. SEE MDR 3015425075-2024-00008. IN (B)(6) 2025 THE PATIENT AGAIN REPORTED TO A NALU REPRESENTATIVE THAT ONE LEAD WAS PUSHING THROUGH THE INCISION SITE. PATIENT PROVIDED A PICTURE SHOWING A CLEAR DEHISCENCE OF THE SURGICAL SITE AND EXPOSED LEAD. THE PHYSICIAN WAS NOTIFIED AND ADVISED THE PATIENT TO GO TO THE LOCAL EMERGENCY DEPARTMENT FOR EVALUATION AND POSSIBLE IMMEDIATE EXPLANT. PATIENT DECLINED TO FOLLOW MEDICAL ADVICE AND DID NOT GO TO BE EVA

  Patient problems: Wound Dehiscence

  MAUDE report 21728556 ↗