Nalu Medical, Inc. 71005-US (UDI 00812537036137)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00812537036137), received between Mar 24, 2022 and Sep 25, 2026 — classified as 71 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2024Class IIOpen, Classified

   Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

   Z-2257-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  The Nalu Representative (rep) reported that the patient was seen for an activation appointment one week post implant. It was noted during the appointment that the IPG incision site is somewhat painful and is oozing clear liquid. The incision is stapled, not red or swollen. The Patient reports that they were instructed by someone at the surgery center to remove the post-op dressing on the surgery day. Patient removed the dressing and the surgical sites remained uncovered for the entire week after surgery. It is unknown what staff member gave those instructions of if possibly the patient misunderstood instructions. The Physician prescribed an additional round of antibiotics, placed collagen and new bandage over the site. It was further reported that the incision site has fully healed without further intervention. There is no evidence of infection.

  Patient problems: Wound Infection

  MAUDE report 50899605 ↗
• MalfunctionSep 23, 2026Impedance Problem

  The Nalu Sales Representative (rep) reported impedance issues during implant procedure as well as during initial activation and programming, so she tried to utilize tight bipoles as close to the PSP algorithm suggested locations on lead B as possible. The patient seemed to have decent coverage and went out of town after that programming. No equipment was replaced and all components remained implanted. There was no reported patient harm or injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867972 ↗
• MalfunctionSep 22, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862569 ↗
• InjuryFeb 15, 2026Improper or Incorrect Procedure or Method

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK WITH THE LEADS TARGETING THE THORACIC NERVE. IMMEDIATELY UPON ACTIVATION OF THE SYSTEM, THE PATIENT NOTED CONNECTIVITY ISSUES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPG AND REPLACE IT WITH A NEW ONE AS WELL AS REPOSITION THE EXISTING LEADS TO BE MORE MIDLINE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24341648 ↗
• InjuryAug 10, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK AND LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS INITIALLY PLACED IN THE LEFT FLANK AREA, WITH THE LEADS TARGETING THE THORACIC NERVE. AFTER IMPLANTING THE SYSTEM, THE PATIENT SUSTAINED A FALL WHICH CAUSED THE IPG TO MIGRATE TO A POSITION DIRECTLY OVER THE SPINE. AFTER THE FALL THE PATIENT NOTED ISSUES WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, AS WELL AS DISCOMFORT AT THE LOCATION OF THE IPG. TESTING OF THE SYSTEM SHOWED THE SYSTEM CONTINUED TO FUNCTION AS EXPECTED AFTER MIGRATION, INDICATING NO DAMAGE TO THE IMPLANTED COMPONENTS. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO MOVE THE MIGRATED IPG TO THE RIGHT FLANK AREA TO CORRECT THE COMMUNICATION ISSUES AND ALLEVIATE PATIENT DISCOMFORT. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE IMPLANTED. SEE MDR 3015425075-2025-00092. AFTER THE REVISION WAS PERFORMED, INTRA-OP AND POST-OP TESTING FOUND THE SYSTEM TO BE FUNCTIONING AS EXPECTED AND THE PATIENT PROCEDED TO USE THE SYSTEM FOR APPROXIMATELY ONE MONTH BEFORE REPORTING NEW ISSUES WITH CONNE

  Patient problems: Inadequate Pain Relief

  MAUDE report 22768327 ↗
• InjuryApr 28, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BAC PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS IN THE VICINITY OF T8-T10. IN (B)(6) 2023 THE PATIENT REPORTED SOME SKIN IRRITATION FROM THE EXTERNAL ADHESIVE CLIPS AND SWITCHED TO A SILICONE STYLE ADHESIVE CLIP TO REDUCE SKIN REACTION. THE SKIN IRRITATION WAS ALLEVIATED AND NO FURTHER ISSUES WERE REPORTED AFTER CHANGING ADHESIVE TYPE UNTIL (B)(6) 2025. ON (B)(6) 2025 THE PATIENT CONTACTED A NALU REPRESENTATIVE AND PROVIDED A PICTURE OF SKIN BREAKDOWN WITH WHAT APPEARED TO BE AN OPEN WOUND. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH THE PHYSICIAN. PHYSICIAN NOTED THAT THE WOUND WAS OVER TOP OF THE LOCATION WHERE THE IPG WAS IMPLANTED, HOWEVER NOT AT ANY INCISION SITES AND APPEARED SUPERFICIAL AND NOT AFFECTING THE IPG. DUE TO THE PROXIMITY OF THE WOUND TO THE LOCATION OF THE IPG, THE PHYSICIAN ELECTED TO EXPLANT THE NALU SYSTEM. SWABS WERE TAKEN AT THE TIME OF EXPLANT AND SENT FOR LAB CULTURES HOWEVER THE RESULTS OF THE CULTURE ARE UNKNOWN AT THE TIME OF REPORTING.

  Patient problems: Unspecified Infection

  MAUDE report 21923319 ↗
• InjuryApr 27, 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 LOWER BACK PAIN. IN (B)(6) 2024 THE PATIENT INDICATED IN A SURVEY THAT THE PAIN LEVEL HAD BEEN REDUCED FROM 8/10 DOWN TO 3/10 WITH USE OF THE NALU SYSTEM. ON 04/12/2025 A NALU REPRESENTATIVE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WAS SCHEDULED TO HAVE THE NALU SYSTEM EXPLANTED. THE REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF THE SCHEDULED PROCEDURE AND WAS TOLD BY THE PATIENT THAT THE SYSTEM WAS NO LONGER PROVIDING RELIEF AND WAS CAUSING "PINCHING" WHEN ACTIVATED. THE PATIENT WAS OFFERED REPROGRAMMING AND OTHER TROUBLESHOOTING HOWEVER REFUSED AND ADAMANTLY REQUESTED REMOVAL. FLUOROSCOPIC IMAGING WAS DONE ON (B)(6) 2025 PRIOR TO EXPLANT AND THE PHYSICIAN STATED THAT THERE WAS NO OBVIOUS MIGRATION OR OTHER ISSUES WITH THE SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE THE PHYSICIAN VISUALLY EVALUATED THE SYSTEM AND PLACEMENT AND AGAIN NOTED THAT THERE WAS NO OBVIOUS ISSUES WITH THE SYSTEM OR PLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21915928 ↗
• InjuryMar 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE 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 IMPLANTED IN THE LOWER BACK AREA WITH 2 LEADS IMPLANTED ON THE RIGHT SIDE OF THE BACK. IMMEDIATELY AFTER ACTIVATION OF THE SYSTEM, THE PATIENT REPORTED PAIN SYMPTOMS DECREASED FROM (B)(6) DOWN TO (B)(6). AT SOME POINT IN 2024 THE PATIENT SUSTAINED A FALL AND WAS EVALUATED IN A LOCAL EMERGENCY DEPARTMENT, DATE IS UNKNOWN. AFTER THE FALL THE PATIENT NOTED THAT THERE WAS INTENSE PAIN SYMPTOMS WHILE THE NALU SYSTEM WAS ACTIVATED. TROUBLESHOOTING WAS ABLE TO ISOLATE THE SYMPTOMS TO ONE OF THE NALU LEADS AND THAT LEAD WAS REMOVED FROM PROGRAMMING. THE PATIENT CONTINUED TO USE THE STIMULATOR WITH A SINGLE LEAD FOR APPROXIMATELY ONE MONTH BEFORE THEN REPORTING RETURN OF THE PAIN SYMPTOMS WHILE USING THE STIMULATOR. PATIENT CEASED USING THE NALU SYSTEM COMPLETELY DUE TO THE INCREASED PAIN WHILE USING IT, EVEN WITH VERY LOW LEVELS OF STIMULATION. XRAY IMAGING WAS DONE AND WAS NOT CONCLUSIVE IN IDENTIFYING THE CAUSE OF THE PAIN SYMPTOMS. ON (B)(6) 2025 A FULL SYSTEM EXPLANT TOOK PLACE.

  Patient problems: Implant Pain

  MAUDE report 21724462 ↗
• InjuryMar 22, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT LOWER BACK AND LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS INITIALLY PLACED IN THE LEFT FLANK AREA, WITH THE LEADS TARGETING THE THORACIC NERVE. AFTER IMPLANTING THE SYSTEM, THE PATIENT SUSTAINED A FALL WHICH CAUSED THE IPG TO MIGRATE TO A POSITION DIRECTLY OVER THE SPINE. AFTER THE FALL THE PATIENT NOTED ISSUES WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, AS WELL AS DISCOMFORT AT THE LOCATION OF THE IPG. TESTING OF THE SYSTEM SHOWED THE SYSTEM CONTINUED TO FUNCTION AS EXPECTED AFTER MIGRATION, INDICATING NO DAMAGE TO THE IMPLANTED COMPONENTS. ON (B)(6)2025 A SURGICAL REVISION WAS PERFORMED TO MOVE THE MIGRATED IPG TO THE RIGHT FLANK AREA TO CORRECT THE COMMUNICATION ISSUES AND ALLEVIATE PATIENT DISCOMFORT. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21671727 ↗
• InjuryFeb 19, 2025Impedance Problem; Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK AND UPPER LEG PAIN. ON (B)(6) 2024, THE PATIENT WAS SEEN FOR PRE-MRI TESTING AND WAS FOUND TO HAVE IMPEDANCE ERRORS ON ONE CONTACT OF AN IMPLANTED LEAD, AND THUS WAS UNABLE TO HAVE THE MRI. THE PATIENT REQUESTED TO HAVE THE NALU SYSTEM REMOVED AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417891 ↗
• InjuryFeb 19, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. PATIENT HAD PARTICIPATED IN A SUCCESSFUL TRIAL PHASE WITH NALU IN WHICH THE PATIENT REPORTED REDUCTION IN PAIN LEVELS FROM 8/10 DOWN TO 2/10. SHORTLY AFTER ACTIVATING THE PERMANENT SYSTEM THE PATIENT BEGAN TO EXPERIENCE ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING FOUND THAT THE IPG HAD MIGRATED WITHIN THE POCKET AND WAS SEATED SO THAT IT WAS NO LONGER PARALLEL TO THE SKIN SURFACE, CAUSING THE COMMUNICATION ISSUES. ON (B)(6) 2025, A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE EXISTING IPG SO THAT IT IS IN THE PROPER POSITION FOR OPTIMAL COMMUNICATION WITH EXTERNAL COMPONENTS. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE INTRODUCED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21417218 ↗
• InjuryJan 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6)2024. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK WITH THE IMPLANTED LEAD CONTACTS TARGETING THE THORACIC NERVE IN THE VICINITY OF T8-T10. ON (B)(6)2024 THE PATIENT PRESENTED TO THE MEDICAL FACILITY FOR AN EXPLANT. PER THE FACILITY, THE PROCEDURE WAS CONSIDERED URGENT AND WAS BEING PERFORMED DUE TO COVID-RELATED COMPLICATIONS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6)2024. NO NALU PERSONNEL WERE PERMITTED TO BE PRESENT FOR THE PROCEDURE DUE TO PATIENT'S COVID STATUS. THE EXPLANTED DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187578 ↗
• InjuryJan 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK AND FOOT PAIN. ON (B)(6) 2024 THE PATIENT NOTIFIED A NALU REPRESENTATIVE THAT THE SYSTEM HAD BEEN EXPLANTED ON (B)(6) 2024 DUE TO SURGICAL WOUND DEHISCENCE AND IMPLANT EXPOSURE.

  Patient problems: Wound Dehiscence

  MAUDE report 21076228 ↗
• InjuryJan 5, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6)2023 TO REPLACE A PRE-EXISTING SYSTEM FROM A DIFFERENT MANUFACTURER. THE NALU SYSTEM WAS PLACED WITH THE IMPLANTABLE PULSE GENERATOR (IPG) IN THE LOWER BACK AREA AND THE IMPLANTED LEADS TARGETING THE THORACIC NERVE TO TREAT LOWER BACK AND UPPER LEG PAIN. THE PATIENT REPORTED FEELING PARESTHESIA IN THE APPROPRIATE LOCATION, HOWEVER WAS UNHAPPY WITH THE LEVEL OF PAIN RELIEF BEING ACHIEVED WITH THE SYSTEM. THE PATIENT WAS SEEN FOR SEVERAL REPROGRAMMING SESSIONS BEFORE ULTIMATELY BECOMING UNCOMMUNICATIVE OR UNRESPONSIVE TO NALU PERSONNEL FOR APPROXIMATELY 9 MONTHS. IN (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS SCHEDULED TO HAVE THE NALU SYSTEM REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6)2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21076212 ↗
• InjuryJan 4, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK AND UPPER LEG PAIN. AT THE TIME OF IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA. PATIENT REPORTED SIGNIFICANT REDUCTION IN PAIN SCORE WHILE USING THE NALU SYSTEM. LATE IN 2024 THE PATIENT NOTED THAT THE IPG WAS NO LONGER COMMUNICATING CONSISTENTLY WITH THE EXTERNAL COMPONENTS AND FIELD ASSESSMENT FOUND THAT THE COMMUNICATION ISSUES WERE DUE TO DEPTH AND POSITION OF THE IPG. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO REPOSITION THE IPG. DURING THE PROCEDURE THE ORIGINAL IPG WAS REMOVED FROM THE POCKET AND TESTED TO CONFIRM IT WAS FUNCTIONING AS EXPECTED. NO ISSUES WERE NOTED WITH THE DEVICE, HOWEVER THE PHYSICIAN WAS CONCERNED WITH POTENTIAL HANDLING DAMAGE DURING THE PROCEDURE AND ELECTED TO PLACE A NEW IPG. THE NEW COMPONENT WAS PLACED MORE MEDIAL AND MORE SUPERFICIAL TO CORRECT THE COMMUNICATION ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21075729 ↗
• InjuryDec 1, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO REPLACE AN EXISTING NEUROMODULATION SYSTEM FROM A DIFFERENT MANUFACTURER. IN (B)(6) 2024, APPROXIMATELY 3 MONTHS AFTER IMPLANTING THE NALU SYSTEM, THE PATIENT REQUESTED TO HAVE IT REMOVED DUE TO DIFFICULTY PLACING THE EXTERNAL COMPONENTS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815736 ↗
• InjuryOct 12, 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 BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE IMPLANTED LEADS TARGETING THE CLUNEAL NERVE. AFTER IMPLANTING THE SYSTEM, THE SURGICAL WOUND ON THE LOWER BACK AREA FAILED TO PROPERLY HEAL. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE EXISTING IPG AND PLACE A NEW ONE IN A SLIGHTLY DIFFERENT LOCATION TO ALLOW THE ORIGINAL SURGICAL SITE TO HEAL.

  Patient problems: Impaired Healing

  MAUDE report 20435279 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK WITH THE IMPLANTED LEADS TARGETING THE VICINITY OF T8-T10. NO NOTABLE INCIDENTS TOOK PLACE DURING THE IMPLANT PROCEDURE AND THE SYSTEM WAS SUCCESSFULLY ACTIVATED. IN (B)(6) 2024 THE PATIENT REPORTED REDUCTION OF PAIN FROM 7/10 DOWN TO 3/10. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT FELT UNWELL AND WENT TO THE LOCAL EMERGENCY DEPARTMENT FOR EVALUATION. AT THAT TIME THE PATIENT WAS NOTED TO HAVE AN INFECTION IN THE EPIDURAL SPACE NEAR THE SURGICAL IMPLANT SITE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 DUE TO THE PRESENCE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20359877 ↗
• InjuryOct 2, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN AFTER SUCCESSFULLY COMPLETING A TRIAL PHASE WITH NALU. DURING THE TRIAL THE PATIENT REPORTED GOOD PAIN RELIEF AND ELECTED TO MOVE FORWARD WITH IMPLANTING THE PERMANENT SYSTEM. DURING THE IMPLANT PROCEDURE FOR THE PERMANENT SYSTEM, THE PHYSICIAN VERBALIZED SOME DIFFICULTY WITH ACCESSING THE EXACT PLACEMENT OF THE TRIAL LEADS, BUT ULTIMATELY IMAGING APPEARED TO SHOW THE PLACEMENT OF BOTH THE TRIAL AND PERMANENT LEADS TO BE THE SAME. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED NOT FEELING ANY STIMULATION AT THE PAIN LOCATION ON THE RIGHT SIDE OF THE BACK, ONLY THE LEFT SIDE. PATIENT REQUESTED TO REVISE THE SYSTEM. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE EXISTING SYSTEM AND REPLACE IT WITH NEW LEADS IN A SLIGHTLY DIFFERENT POSITION TO BETTER CAPTURE THE PATIENT'S PAIN LOCATION AND PROVIDE RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20355405 ↗
• InjurySep 30, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT RIGHT FOOT PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK WITH THE LEADS PLACED IN THE VICINITY OF T8-T10. UPON ACTIVATING THE SYSTEM, THE PATIENT REPORTED GETTING THERAPY IN THE FOOT, HOWEVER UNSATISFIED WITH THE LEVEL OF PAIN RELIEF. TROUBLESHOOTING AND PROGRAMMING WERE DONE TO IMPROVE THERAPY BUT WERE NOT SUCCESSFUL. FIELD INVESTIGATION WITH PHYSICIAN CONCLUDED THAT THE LEADS HAD SHIFTED DOWNWARD SLIGHTLY, SO STILL PROVIDING THERAPY TO THE FOOT BUT NOT TO THE SPECIFIC AREA IN THE FOOT THAT IS INTENDED. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE EXISTING LEADS BACK AT THE TARGET LOCATION OF T8-T10.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20335251 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. ON (B)(6) 2024 THE PATIENT CONTACTED A LOCAL NALU REPRESENTATIVE TO REPORT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS VISIBLY PROTRUDING FROM THE SKIN WHERE IT HAD BEEN IMPLANTED IN THE LOWER BACK AREA. PATIENT REPORTED NO PAIN OR DISCOMFORT AT THE SITE AND NO REDNESS OR DRAINAGE WAS NOTED. PATIENT WAS INSTRUCTED TO CONTACT THE IMPLANTING PHYSICIAN FOR FOLLOW-UP AND THE FIRM REPRESENTATIVE ALSO NOTIFIED THE PHYSICIAN OF THE PATIENT STATUS. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE SKIN EROSION WITH EXPOSED IMPLANT.

  Patient problems: Skin Erosion

  MAUDE report 20090744 ↗
• InjuryAug 15, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023 TO TREAT LOWER BACK PAIN. AFTER IMPLANTING THE SYSTEM THE PATIENT DISCOVERED THE NEED FOR AN MRI TEST AS WELL AS POTENTIAL BACK SURGERY. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6)2024 IN ORDER TO ALLOW FOR THE MRI AND PREPARE FOR POTENTIAL SURGERY IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988874 ↗
• InjuryJul 24, 2024Malposition of Device; Malposition of Device

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED PERSISTENT ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO MOVE THE IPG FROM THE FLANK AREA TO APPROXIMATELY 1.5 INCHES INFERIOR TO A FLATTER AREA ON THE BACK AS WELL AS BRINGING THE IPG MORE SUPERFICIAL TO IMPROVE COMMUNICATION. DURING THE PROCEDURE THE IPG WAS FOUND TO BE SURROUNDED BY SCAR TISSUE AND WAS DAMAGED WHILE ATTEMPTING TO REMOVE THE DEVICE. A NEW IPG WAS INTRODUCED IN THE NEW LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19822229 ↗
• InjuryJul 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 AFTER SUCCESSFULLY COMPLETING A TRIAL PHASE WITH THE NALU SYSTEM. DURING THE TRIAL PHASE THE PATIENT REPORTED PAIN WAS REDUCED FROM 7/10 DOWN TO 2/10 ALONG WITH A DECREASE IN PAIN MEDICATION NEEDS. THE PERMANENT SYSTEM WAS PLACED WITH THE LEADS TARGETING THE THORACIC NERVE AT THE VICINITY OF T8-T10. IN (B)(6) 2024 THE PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED DUE TO REPORTS OF INADEQUATE PAIN RELIEF AND NAUSEA WHEN USING THE SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief; Nausea

  MAUDE report 19787743 ↗
• InjuryJul 11, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. UPON ACTIVATING THE SYSTEM THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT CONSISTENTLY COMMUNICATING WITH THE EXTERNAL THERAPY DISCS, THUS NOT PROVIDING ADEQUATE PAIN RELIEF TO THE PATIENT. XRAY IMAGING FOUND THAT THE IPG HAD MIGRATED WITHIN THE POCKET. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE IPG. NO COMPONENTS WERE EXPLANTED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19727410 ↗