Nalu Medical, Inc. 72006Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00812537037370), received between Sep 24, 2024 and Sep 21, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Migration” (10 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 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Migration

  Patient problems: Insufficient Information

  MAUDE report 50844620 ↗
• InjuryMar 30, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT HEAD PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH THE LEADS PLACED AT THE C2-C3 LATERAL MASSES, CONSISTENT WITH A CERVICAL MEDIAL BRANCH TARGET. IN (B)(6) 2025 THE PATIENT CONTACTED A NALU REPRESENTATIVE TO REPORT LOSS OF STIMULATION. THE PATIENT COMPLETED A REMOTE IMPEDANCE TEST AND FOUND THE RIGHT (B SIDE) LEAD SHOWED IMPEDANCE ERRORS ON ALL 4 CONTACTS. ASSESSMENT OF THE SYSTEM CONFIRMED THAT LEAD WAS NOT DELIVERING STIMULATION AND HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON (B)(6) 2026 THE PATIENT WAS BROUGHT IN FOR SURGICAL REVISION. DURING THE REVISION THE LEAD WAS CONNECTED TO A KNOWN-GOOD IPG AND CONFIRMED THAT THE LEAD ITSELF WAS MALFUNCTIONING.THE MALFUNCTIONING LEAD WAS REMOVED AND REPLACED AS WELL AS REPLACING THE ORIGINAL IPG OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24723037 ↗
• InjuryJan 20, 2026Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT SHOULDER PAIN. THE PATIENT HAD A PRE-EXISTING NEUROSTIMULATION SYSTEM FROM A DIFFERENT MANUFACTURER THAT WAS TREATING THAT SAME LOCATION AND THE NALU SYSTEM WAS IMPLANTED TO REPLACE THAT PRIOR SYSTEM. NO TRIAL PHASE WAS CONDUCTED WITH NALU DUE TO THE PRESENCE OF A DIFFERENT SYSTEM. DURING ACTIVATION OF THE NALU SYSTEM IT WAS NOTED THAT THE PATIENT WAS VERY SENSITIVE TO THE STIMULATION BUT WAS UNABLE TO GET GOOD PAIN RELIEF WITH SUB-PERCEPTION PROGRAMMING. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO MOVE THE EXISTING LEADS TO A SLIGHTLY DIFFERENT POSITION TO REDUCE SENSITIVITY AND IMPROVE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24114340 ↗
• InjuryJan 20, 2026Fracture

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BACK PAIN. ON (B)(6) 2025, THE PATIENT STOPPED USING THE SYSTEM FOR UNSPECIFIED REASONS. NALU PERSONNEL MADE MULTIPLE EFFORTS TO REACH OUT TO THE PATIENT TO PROVIDE SUPPORT TO RE-ESTABLISH THERAPY HOWEVER THE PATIENT WAS NOT RECEPTIVE TO THE COMMUNICATION AND SUPPORT EFFORTS. ON (B)(6) 2025, A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114338 ↗
• InjuryJan 20, 2026High impedance

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. APPROXIMATELY 2 MONTHS AFTER IMPLANT THE PATIENT REPORTED A DECLINE IN THERAPY. THE PATIENT WAS SEEN FOR REPROGRAMMING AND TROUBLESHOOTING AND IT WAS DISCOVERED THAT ONE OF THE IMPLANTED LEADS HAD BAD IMPEDANCE READINGS ON ALL ELECTRODES AND THE SECOND LEAD HAD BAD IMPEDANCE READINGS ON 2 OUT OF 4 ELECTRODES. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MALFUNCTIONING LEADS AND PLACE NEW LEADS. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED OUT OF CAUTION.

  Patient problems: Implant Pain

  MAUDE report 24114337 ↗
• InjuryNov 16, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT BACK PAIN. IN APPROXIMATELY (B)(6) 2025 THE PATIENT NOTED A REDUCTION IN PAIN RELIEF AS WELL AS REPORTED MUSCLE SPASMS. THE PATIENT REQUESTED REPROGRAMMING AND WAS SEEN SEVERAL TIMES TO REDUCE THE INTENSITY WITHOUT IMPROVEMENT OF SYMPTOMS. IMAGING WAS DONE AND REVEALED THE LEADS HAD MIGRATED AWAY FROM THE INITIAL PLACEMENT. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE LEADS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Inadequate Pain Relief

  MAUDE report 23565865 ↗
• InjuryNov 5, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT BACK PAIN. ON (B)(6) 2025 THE PATIENT REPORTED AN INCREASE IN PAIN SYMPTOMS AND TESTING OF THE IMPLANTED SYSTEM FOUND BOTH LEADS TO HAVE IMPEDANCE ERRORS. IMAGING WAS PERFORMED AND SHOWED NO MIGRATION. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE ORIGINAL SYSTEM AND PLACE A NEW SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23473186 ↗
• 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) 2025 TO TREAT FOOT PAIN. IN APPROXIMATELY (B)(6) 2025 THE IMPLANTED LEADS WERE NOTED TO HAVE BECOME EXPOSED THROUGH THE SKIN, CAUSING PAIN AND INTRODUCING INCREASED RISK OF INFECTION. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Skin Erosion

  MAUDE report 23473185 ↗
• InjuryOct 15, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT KNEE PAIN. IN (B)(6) 2025 THE PATIENT REACHED OUT TO A LOCAL NALU REPRESENTATIVE FOR ASSISTANCE WITH SYNCING A NEW PHONE WITH THE NALU REMOTE APPLICATION. WHILE ASSISTING WITH THE SYNC PROCESS, THE SYSTEM WAS ASSESSED AND FOUND TO HAVE IMPEDANCE ERRORS ON ONE OF THE LEADS. THE PATIENT HAD NOT NOTED ANY CHANGE IN THERAPY AND WAS FULLY UNAWARE OF ANY ISSUES. IMAGING WAS PERFORMED AND SHOWED NO OBVIOUS ISSUES WITH THE IMPLANTED COMPONENTS. ALTHOUGH THE PATIENT HAD NOT NOTED ANY ISSUES WITH THERAPY, THE PHYSICIAN ELECTED TO REPLACE THE MALFUNCTIONING LEAD. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE MALFUNCTIONING LEAD AND PLACE A NEW LEAD. DURING THE PROCEDURE THE IPG WAS ALSO REPLACED OUT OF CAUTION. DURING THE REVISION PROCEDURE THE PHYSICIAN PLACED PRESSURE ON THE LEAD WHILE ATTEMPTING TO REMOVE IT AND THE LEAD FRACTURED JUST PROXIMAL TO THE TINED END. THE PROCEDURE INCLUDED DISSECTING DOWN TO REMOVE THE REMAINING PORTION OF THE LEAD THAT HAD SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306108 ↗
• InjurySep 6, 2025Device Handling Problem; Device Handling Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN AFTER HAVING COMPLETED A SUCCESSFUL TRIAL PHASE WITH NALU. IN (B)(6) 2025 THE PATIENT EXPRESSED TO A NALU REPRESENTATIVE THAT THE SYSTEM WAS NOT PROVIDING THE LEVEL OF PAIN RELIEF EXPECTED AND THE PATIENT WAS FRUSTRATED WITH THE PERCIEVED LIMITATIONS OF THE SYSTEM IN GENERAL. AN APPOINTMENT WAS ARRANGED FOR THE SYSTEM TO BE EVALUATED AND POSSIBLE REPROGRAMMING TO OPTIMIZE THERAPY. DURING THE SESSION THE NALU REPRESENTATIVE PRESENT CONFIRMED GOOD COMMUNICATION WAS ACHIEVED BETWEEN ALL COMPONENTS AND STIMULATION APPEARED TO BE RECEIVED AT THE APPROPRIATE LOCATION BEING TREATED. REPROGRAMMING WAS INITIATED BUT THE PATIENT AGAIN EXPRESSED FRUSTRATION AND THE APPOINTMENT WAS ENDED PREMATURELY BY THE PATIENT WITHOUT HAVING COMPLETED THE REPROGRAMMING PROCESS. A SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST (SEE MDR 3015425075-2025-00246). DURING THE EXPLANT PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS UNABLE TO COMFORTABLY REMOVE THE IMPLANTED LEAD AND ELECTED TO CUT THE LEAD, LEAVING THE DISTAL END FRAGMENT IMPLANTED. ON (B)(6) 2025 THE FIRM WAS NOTIFIE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22989074 ↗
• InjurySep 6, 2025Impedance Problem; Impedance Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2025 TO TREAT BILATERAL BACK PAIN. APPROXIMATELY 2 WEEKS AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED LOSS OF STIMULATION TO THE RIGHT SIDE. TESTING OF THE SYSTEM FOUND OPEN CIRCUIT IMPEDANCE READINGS ON 3 OUT OF THE 4 ELECTRODES ON THE RIGHT-SIDE IMPLANTED LEAD. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE FAULTY LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22989071 ↗
• InjurySep 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 WITH THE SYSTEM BEING ACTIVATED ON (B)(6) 2025. DURING ACTIVATION OF THE SYSTEM, IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY TO THE DESIRED LOCATION. IN (B)(6) 2025 THE PATIENT REPORTED THAT THERAPY WAS NOT PROVIDING ANY RELIEF AND THAT THE STIMULATION WAS CAUSING THE PATIENT TO FEEL OFF BALANCE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: Balance Problems; Inadequate Pain Relief

  MAUDE report 22989070 ↗
• InjuryAug 10, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT KNEE PAIN. THE PATIENT COMPLETED SEVERAL SURVEYS AFTER IMPLANTING THE SYSTEM AND CONSISTENTLY REPORTED REDUCTION IN PAIN SYMPTOMS BY APPROXIMATELY 50%. ONE SUCH SURVEY WAS COMPLETED BY THE PATIENT ON (B)(6) 2025 AND REPORTED PAIN LEVELS AT 3/10. ON (B)(6) 2025 THE PATIENT WAS SEEN IN THE MEDICAL CLINIC AND A NALU REPRESENTATIVE PRESENT DISCOVERED IMPEDANCE ERRORS ON THE PATIENT'S MEDIAL LEAD. IMAGING WAS PERFORMED ON (B)(6) 2025 AND DOES NOT APPEAR TO SHOW ANY DAMAGE OR MIGRATION OF THE IMPLANTED LEADS. THE PATIENT CONTINUED TO REPORT RECEIVING GOOD PAIN RELIEF, HOWEVER REQUESTED INTERVENTIONS TO CORRECT THE IMPEDANCE ERROR AND OPTIMIZE THERAPY. ON (B)(6) 2025 A SURGICAL INTERVENTION WAS PERFORMED IN WHICH THE MALFUNCTIONING LEAD WAS REPOSITIONED AND RECONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG). AFTER RECONNECTING THE LEAD, ALL TESTING RETURNED GOOD READINGS AND THE PATIENT REPORTED RECEIVING GOOD THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768332 ↗
• InjuryJul 30, 2025Migration; Migration

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2024 TO REPLACE AN EXISTING STIMULATION DEVICE FROM A DIFFERENT MANUFACTURER. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK WITH THE LEADS TARGETING THE INTERCOSTAL NERVE TO TREAT ABDOMINAL PAIN. AFTER IMPLANTING THE SYSTEM, ONE OF THE LEADS MIGRATED, CAUSING THE LOSS OF THERAPY TO THE DESIRED LOCATION. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE 4-CONTACT LEAD THAT HAD MIGRATED AND PLACE A NEW 8-CONTACT LEAD AT THAT LOCATION. DURING THE PROCEDURE, THE IPG REQUIRED REPLACEMENT WITH A NEW IPG THAT WOULD ACCOMODATE THE 8-CONTACT LEAD. THE EXISTING 4-CONTACT LEAD THAT DID NOT MIGRATE WAS LEFT IN PLACE AND REMAINS IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22671846 ↗
• InjuryJul 11, 2025Fracture; Fracture

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2024 TO TREAT RIGHT KNEE PAIN, IN (B)(6) 2025 IT WAS DISCOVERED THAT ONE OF THE IMPLANTED LEADS HAD FRACTURED, THUS CAUSING LOSS OF THERAPY AT THAT LOCATION. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE FRACTURED LEAD. DURING THE REVISION THE PHYSICIAN ELECTED TO FULLY REMOVE BOTH THE FRACTURED LEAD AND THE INTACT LEAD AND REPLACE THE ORIGINAL 25CM LEADS WITH NEW 40CM LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22479132 ↗
• InjuryJul 2, 2025Fracture; Fracture

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2024 TO TREAT KNEE PAIN. AFTER THE IMPLANT WAS ACTIVATED, THE PATIENT REPORTED HAVING LOST THERAPY FROM ONE OF THE IMPLANTED LEADS. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE MALFUNCTIONING LEAD AND PLACE A NEW ONE. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED OUT OF CAUTION TO AVOID ANY POTENTIAL FOR HANDLING DAMAGE DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22391744 ↗
• InjuryJun 27, 2025Fracture; Migration; Fracture; Migration

  A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2025 TO TREAT KNEE PAIN. IN (B)(6) 2025 THE PATIENT REPORTED REDUCTION IN THERAPY BEING DELIVERED AND TESTING OF THE SYSTEM FOUND OPEN CIRCUIT IMPEDANCE READINGS ON ONE OF THE IMPLANTED LEADS. SOME LEVEL OF PAIN RELIEF WAS ABLE TO BE ACHIEVED AT THAT TIME WITH USE OF A SINGLE LEAD. IN (B)(6) 2025 THE SYSTEM WAS ASSESSED AND IMAGING SHOWED THAT THE IMPLANTED LEAD HAD MIGRATED AND FRACTURED, REQUIRING SURGICAL INTERVENTION TO CORRECT. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR A SYSTEM REVISION. THE PROCEDURE BECAME MORE INVASIVE THAN THE PHYSICIAN HAD ANTICIPATED AND THE DECISION WAS MADE TO REMOVE THE SYSTEM AND ALLOW HEALING BEFORE INTRODUCING A NEW SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22343162 ↗
• InjuryMay 4, 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 ABDOMINAL PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE ABDOMEN WITH THE LEADS TARGETING THE TRANSABDOMINAL PLANE. ON (B)(6) 2025 THE PATIENT PROVIDED A PICTURE TO A NALU REPRESENTATIVE OF WHAT APPEARED TO BE AN EXPOSED LEAD. THE PATIENT WAS REFERRED TO THE PHYSICIAN WHO EXPLANTED THE ENTIRE SYSTEM ON (B)(6) 2025.

  Patient problems: Wound Dehiscence

  MAUDE report 21955952 ↗
• InjuryMar 23, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER EXTREMITY PAIN. THE PATIENT HAD REPORTED PAIN LEVELS DECREASED FROM 9/10 DOWN TO 2/10 WHILE USING THE TRIAL SYSTEM AND IN A SURVEY COMPLETED ON (B)(6) 2024 PAIN LEVELS WERE REPORTED TO BE 3/10 WITH THE PATIENT REPORTING SATISFACTION WITH THE SYSTEM AND BEING HIGHLY LIKELY TO RECOMMEND IT TO OTHERS. IN (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS ONLY GETTING MINIMAL PAIN RELIEF AND WANTED TO EXPLANT THE NALU SYSTEM SO THAT AN MRI COULD BE COMPLETED. AT THIS TIME THE PATIENT BECAME UNRESPONSIVE TO COMMUNICATION FROM THE FIRM. ON (B)(6) 2025 THE FIRM WAS ABLE TO MAKE CONTACT WITH THE PATIENT AND LEARNED THAT THE NALU SYSTEM HAD BEEN EXPLANTED SOME TIME IN (B)(6) 2024, EXACT DATE WAS UNKNOWN. THE PATIENT STATED THAT IT FELT AS IF THE STIMULATION FROM THE NALU SYSTEM WAS NOT GETTING TO THE RIGHT PLACE AND THUS THE MINIMAL PAIN RELIEF AND DESIRE FOR EXPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21673421 ↗
• InjuryFeb 10, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. ON (B)(6) 2024 THE SYSTEM WAS ACTIVATED AND THE PATIENT REPORTED THAT THERAPY WAS NOT BEING FELT IN THE DESIRED LOCATION. XRAY IMAGING FOUND THE IMPLANTED LEAD HAD MIGRATED AWAY FROM THE INITIAL PLACEMENT. REPROGRAMMING WAS PERFORMED SEVERAL TIMES TO ATTEMPT TO IMPROVE THERAPY BUT WAS NOT SUCCESSFUL. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE MIGRATED LEAD. NO COMPONENTS WERE REMOVED OR REPLACED AND NO NEW COMPONENTS WERE INTRODUCED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21351971 ↗
• InjuryJan 17, 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 ON (B)(6) 2024 TO TREAT KNEE PAIN. THE PATIENT REPORTED RECEIVING GOOD PAIN RELIEF FROM THE SYSTEM UPON ACTIVATION. ON (B)(6) 2024 THE FIRM WAS NOTIFIED BY THE IMPLANTING PHYSICIAN THAT THE PATIENT WAS BEING SCHEDULED FOR SURGICAL INTERVENTION DUE TO THE IMPLANTED LEADS BEING EXPOSED THROUGH AN OPEN SURGICAL INCISION. PHYSICIAN WAS UNSURE OF EXACT SURGICAL PLAN AND STATED IT WOULD BE DEPENDENT UPON FINDINGS UPON OPENING THE SITE AND VISUALIZING THE CONDITION. ON (B)(6) 2024 THE PHYSICIAN PERFORMED A FULL SYSTEM EXPLANT DUE TO THE EXPOSED LEADS AND WOUND DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 21185490 ↗
• InjuryJan 17, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LATERAL THIGH AREA WITH THE LEADS TARGETING THE SCIATIC NERVE TO TREAT FOOT PAIN. IN (B)(6) 2024 THE PATIENT REQUESTED ASSISTANCE IN LOCATING A DIFFERENT PHYSICIAN TO PERFORM A REVISION AS THEY WERE NOT GETTING ADEQUATE PAIN RELIEF FROM THE SYSTEM. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO CORRECT LEAD MIGRATION. DURING THE PROCEDURE THE ENTIRE SYSTEM WAS REMOVED AND A NEW ONE PLACED AT THE APPROPRIATE POSITION TO TARGET THE DESIRED NERVE LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21185487 ↗
• InjuryJan 5, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER LEG PAIN. UPON INITIAL ACTIVATION OF THE SYSTEM THE PATIENT REPORTED FEELING STIMULATION BUT THE THERAPY DID NOT REACH ALL THE WAY DOWN INTO THE LOWER LEG AND FOOT AREA, WHICH WAS THE PRIMARY PAIN LOCATION. THE SYSTEM WAS REPROGRAMMED SEVERAL TIMES IN ATTEMPT TO IMPROVE THERAPY. PHYSICIAN DETERMINED THAT THE IMPLANTED LEAD WAS NOT IN THE APPROPRIATE LOCATION TO ADDRESS THE PATIENT'S PAIN AND WOULD NEED TO BE REPOSITIONED OR REVISED. THE MEDICAL FACILITY WHERE THE PATIENT WAS IMPLANTED GAVE THE OPTION TO HAVE THE EXISTING SYSTEM REPOSITIONED OR EXPLANTED ONLY. THE FACILITY POLICY DOES NOT ALLOW FOR ANY COMPONENT REPLACEMENT. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS INITIATED TO REPOSITION THE EXISTING IMPLANTED LEAD TO BETTER ADDRESS THE APPLICABLE NERVE TARGET. DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY REPOSITION THE LEAD AND ULTIMATELY FRACTURED THE LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG), ONE FULL LEAD, AND THE PROXIMAL END OF THE SECOND LEAD WERE EXPLANTED DURING THE PROCEDURE. THE DISTAL END OF THE FRACTURED LEAD WAS UNABLE TO BE REMOVED AND THERE ARE NO PLA

  Patient problems: Inadequate Pain Relief

  MAUDE report 21076237 ↗
• InjuryJan 5, 2025Lack of Effect; Lack of Effect

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT FOOT PAIN AFTER HAVING PARTICIPATED IN A TRIAL PHASE WITH NALU. AFTER ACTIVATING THE SYSTEM ON (B)(6)2024 THE PATIENT REPORTED THAT THE PERMANENT SYSTEM WAS NOT PROVIDING THE SAME LEVEL OF PAIN RELIEF AS WAS FELT WITH THE TRIAL SYSTEM. ON (B)(6)2024 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IMPLANTED LEADS. THE ORIGINAL LEADS WERE PLACED TARGETING ONLY THE TIBIAL NERVE, THE NEW LEAD PLACEMENT INCLUDED BOTH THE TIBIAL AND COMMON PERONEAL NERVES TO BETTER CAPTURE THE PAIN LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21075739 ↗
• InjuryDec 1, 2024Adverse 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, TO TREAT LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE PATIENT'S CALF AREA, WITH THE ATTACHED LEAD WIRES TARGETING THE COMMON PERONEAL NERVE. ON 06/19/2024, THE SYSTEM WAS ACTIVATED AND THERE WERE NO REPORTED ISSUES AT THAT TIME. ON (B)(6) 2024, THE PATIENT NOTIFIED A NALU REPRESENTATIVE. THAT THE LEAD WIRES SEEM TO HAVE ERODED THROUGH THE SKIN AND WERE EXPOSED. THE MEDICAL CLINIC WAS NOTIFIED. AND THE PATIENT WAS SCHEDULED TO BE SEEN THE FOLLOWING DAY. ON (B)(6) 2024, A FULL SYSTEM EXPLANT WAS PERFORMED, DUE TO THE EXPOSED IMPLANT COMPONENTS.

  Patient problems: Skin Erosion

  MAUDE report 20814984 ↗