Nalu Medical, Inc. 71004-US (UDI 00812537033594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00812537033594), received between Oct 12, 2020 and Mar 30, 2025 — classified as 45 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6)2022 TO TREAT LOWER BACK PAIN. AFTER HAVING BEEN IMPLANTED, THE PATIENT REPORTED THAT THE REDUCTION IN PAIN LEVELS LEAD TO A MORE ACTIVE LIFESTYLE AND SIGNIFICANT WEIGHT LOSS. AFTER HAVING LOST APPROXIMATELY 75 POUNDS, THERE BECAME AN ISSUE WITH CONNECTIVITY BETWEEN THE NALU IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A POCKET REVISION WAS PERFORMED ON (B)(6)2023 TO PLACE THE IPG IN A MORE OPTIMAL LOCATION FOR CONNECTIVITY. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE. SEE MDR 3015425075-2023-00098. AFTER REPOSITIONING THE IPG, THE PATIENT CONTINUED TO LOSE WEIGHT AND EVENTUALLY REPORTED A LOSS OF THERAPY FROM THE SYSTEM. TROUBLESHOOTING IN THE FIELD FOUND THAT THE IPG WAS NO LONGER PARALLEL TO THE SKIN SURFACE, BOTH IMPLANTED LEADS HAD ALSO MIGRATED, AND THERE WAS AN OPEN CIRCUIT ERROR REPORTED ON ONE CONTACT OF ONE OF THE LEADS. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE EXISTING NALU SYSTEM AND PLACE A NEW SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21728631 ↗
• InjuryDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS INITIALLY IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2021 TARGETING THE CERVICAL AREA. AFTER USING THE SYSTEM FOR SEVERAL MONTHS THE PATIENT REQUESTED TO MOVE THE IMPLANTABLE PULSE GENERATOR (IPG) TO A DIFFERENT LOCATION. THERE WERE NO REPORTS AT THAT TIME OF ANY SYSTEM OR COMPONENT ISSUES, THE PATIENT FELT THAT A DIFFERENT LOCATION FOR THE IPG WOULD ALLOW THE EXTERNAL COMPONENTS TO STAY ADHERED MORE RELIABLY. A SURGICAL REVISION WAS PERFORMED TO REMOVE THE EXISTING IPG AND PLACE A NEW ONE IN THE PATIENT'S PREFERRED LOCATION ON (B)(6) 2022. SEE MDR 3015425075-2022-00028. ON (B)(6) 2024 THE PATIENT REPORTED A GENERAL HEATING SENSATION AT THE IPG POCKET AND GENERAL ACHES FOR THE PRIOR 24 HOURS. PATIENT ALSO REPORTED THAT THE NALU SYSTEM HAD RECENTLY BEEN TURNED BACK ON AFTER A 2 MONTH BREAK. PATIENT REPORTED NOT HAVING USED THE SYSTEM DUE TO PAIN BEING UNDER CONTROL WITHOUT IT AND THAT THE HEATING AND ACHINESS WAS NOTED AFTER TURNING THE SYSTEM BACK ON. PATIENT WAS ADVISED TO LEAVE THE SYSTEM OFF TILL THE FOLLOWING DAY, THEN TURN IT ON WHILE BEING MONITORED BY NALU PERSONNEL FOR TROUBLESHOOTING. THE PATIENT ALSO NOTED WHICH EXTERNAL THERAPY DISC WAS USE

  Patient problems: Implant Pain

  MAUDE report 21024088 ↗
• InjurySep 22, 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) 2022. IN 2024 THE PATIENT INFORMED A NALU REPRESENTATIVE THAT AN MRI WAS REQUIRED AND THUS AN EXPLANT OF THE NALU SYSTEM WAS BEING REQUESTED. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED TO ALLOW THE PATIENT TO MOVE FORWARD WITH THE MRI TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276173 ↗
• InjuryAug 22, 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 EXTREMITY PAIN. APPROXIMATELY ONE YEAR AFTER IMPLANTING THE SYSTEM, THE PATIENT'S PHYSICIAN REQUESTED AN MRI OF THE SPINE. THE PATIENT WAS UNABLE TO OBTAIN THE MRI DUE TO THE NALU SYSTEM BEING INCOMPATIBLE WITH THE TEST. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 TO ALLOW THE MRI TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044531 ↗
• InjuryAug 3, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) BEING PLACED IN THE PATIENT'S FLANK AREA. AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, CAUSING INTERMITTENT THERAPY AND PAIN RELIEF. PALPATION OF THE IPG SITE FOUND THAT THE LOOSE SKIN AROUND THE SITE ALLOWED THE DEVICE TO MIGRATE BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL COMMUNICATION. ON (B)(6) 2024 A SURGICAL INTERVENTION WAS PERFORMED TO PLACE A NEW IPG IN A MORE SUPERIOR AND MEDIAL LOCATION TO AVOID THE LOOSE SKIN ON THE LOWER FLANK AREA.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19901134 ↗
• InjuryJun 26, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT SHOULDER AND UPPER BACK PAIN. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS SCHEDULED FOR A SURGICAL REVISION ON THAT DATE. INVESTIGATION DISCOVERED THAT THE PATIENT HAD LOST SIGNIFICANT WEIGHT AFTER HAVING THE NALU SYSTEM IMPLANTED, LEADING TO ISSUES WITH CONNECTIVITY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXTERNAL THERAPY DISCS. PROCEDURE ON (B)(6) 2024 WAS INTENDED TO MOVE THE EXISTING IPG TO A MORE STABLE POSITION. DURING THE PROCEDURE THERE WERE CONCERNS OF IPG DAMAGE FROM HANDLING, THUS A REPLACEMENT IPG WAS USED. EXISTING LEADS REMAIN IMPLANTED AND IN USE. THE SYSTEM WAS ACTIVATED ON (B)(6) 2024 AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19620681 ↗
• InjuryJun 15, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. AFTER HAVING THE IMPLANT PERFORMED THE PATIENT GAINED A SIGNIFICANT AMOUNT OF WEIGHT, CAUSING DISRUPTION IN 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 LATERAL LOWER BACK TO A MORE MEDIAL LOCATION ON THE LOWER BACK TO CORRECT THE COMMUNICATION ISSUE. NO COMPONENTS WERE EXPLANTED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19543992 ↗
• InjuryMay 22, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. ON 01APR2024 THE PATIENT WAS SEEN BY A REPRESENTATIVE OF NALU FOR SYSTEM ACTIVATION. THE SYSTEM WAS NOT ABLE TO ESTABLISH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. XRAY IMAGING WAS PERFORMED AND SHOWED THE IPG HAD MIGRATED, CAUSING THE LACK OF COMMUNICATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE THE PHYSICIAN DAMAGED THE EXISTING IPG AND A NEW ONE WAS IMPLANTED IN A MORE OPTIMAL POSITION. INTRA-OP TESTING SHOWED THE SYSTEM WAS FUNCTIONING AS EXPECTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19372438 ↗
• InjuryJan 10, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TARGETING THE OCCIPITAL NERVE. ON 13NOV2023 THE FIRM WAS NOTIFIED THAT THE PATIENT REQUIRED AN MRI AND WAS NOT CONDITIONAL FOR THAT PROCEDURE WITH THE NALU SYSTEM IN PLACE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023 TO ALLOW THE PATIENT TO MOVE FORWARD WITH THE REQUESTED MRI PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490071 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 TARGETING THE THORACIC NERVE. AFTER IMPLANTING THE DEVICE, THE SURGICAL INCISION SITE FAILED TO HEAL. PHYSICIAN REMOVED THE SYSTEM ON (B)(6) 2023 DUE TO SUSPECTED INFECTION AT THE INCISION SITE, HOWEVER ALL CULTURES RETURNED NEGATIVE FOR INFECTION.

  Patient problems: Impaired Healing

  MAUDE report 18207532 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 AND IMMEDIATELY REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, LEADING TO INADEQUATE PAIN RELIEF DUE TO INTERMITTENT THERAPY, TROUBLESHOOTING WAS ATTEMPTED AND UNSUCCESSFUL. A SURGICAL REVISION WAS PERFORMED TO MOVE THE EXISTING IPG TO A MORE SUPERFICIAL LOCATION ON (B)(6) 2023. THE SYSTEM WAS ACTIVATED ON (B)(6) 2023 WITH GOOD CONNECTIVITY AND PROVIDING CONSISTENT THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17956403 ↗
• InjuryOct 8, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR ON (B)(6) 2020. IN (B)(6) 2023 THE PATIENT REPORTED CONNECTIVITY ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, ULTIMATELY CAUSING DISRUPTION IN THERAPY AND INADEQUATE PAIN RELIEF. IT WAS DETERMINED THAT THE IPG HAD MIGRATED DUE TO LOSS OF TISSUE AROUND THE POCKET AREA AFTER THE PATIENT SUSTAINED A SIGNIFICANT LOSS OF WEIGHT. ON (B)(6) 2023 A REVISION PROCEDURE TOOK PLACE IN WHICH THE IPG AND IMPLANTED LEADS WERE REPLACED AND THE NEW IPG WAS PLACED IN A NEW LOCATION WITH SUFFICIENT TISSUE PRESENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17892710 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021, AND HAD ADDITIONAL LEADS PLACED ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT HAD THE FULL SYSTEM EXPLANTED DUE TO THE NEED FOR AN MRI FOR AN UNRELATED MEDICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733953 ↗
• InjuryAug 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT NOTIFIED NALU STAFF OF INTERMITTENT COMMUNICATION ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, CAUSING INTERMITTENT PAIN THERAPY. TROUBLESHOOTING WAS ATTEMPTED, INCLUDING REPLACING EXTERNAL DEVICES, HOWEVER, WAS UNSUCCESSFUL. SUBSEQUENT FLUOROSCOPY IMAGING FOUND THE IPG POSITION WAS BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY WITH THE THERAPY DISCS AND ALSO SHOWED THAT THE IPG WAS HINDERED BY SKIN FOLDS. SURGICAL REVISION ON (B)(6) 2023 MOVED THE IPG MORE SUPERFICIAL, MORE MEDIAL (IN FIRMER TISSUE), AND MORE SUPERIOR.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17581174 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022. AFTER THE IMPLANT THE PATIENT BEGAN TO DISPLAY EARLY SIGNS OF DEMENTIA AND SHOWED DIFFICULTY UNDERSTANDING THE NALU SYSTEM OR ITS PURPOSE AS THE DISEASE PROGRESSED. PHYSICIAN ELECTED TO EXPLANT THE SYSTEM DUE TO PATIENT'S MENTAL STATUS. EXPLANT TOOK PLACE ON (B)(6) 2023 HOWEVER NALU WAS NOT MADE AWARE OF THE PROCEDURE UNTIL 21JUL2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485313 ↗
• InjuryAug 9, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2023. PATIENT SUBSEQUENTLY REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, LEADING TO LOSS OF THERAPY. INVESTIGATION DETERMINED THAT THE IPG HAD MIGRATED AWAY FROM THE POCKET LOCATION, CAUSING THE COMMUNICATION ISSUES REPORTED BY THE PATIENT. FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023 PER PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17485293 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. AFTER IMPLANT, THE PATIENT EXPERIENCED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. IT WAS DETERMINED THAT THE IPG HAD MIGRATED TO A POSITION THAT CAUSED POOR COMMUNICATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO MOVE THE IPG TO A MORE OPTIMAL LOCATION AND RESTORE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17443721 ↗
• InjuryAug 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 AND SUBSEQUENTLY COMPLAINED OF AN UNCOMFORTABLE PRESSURE AT THE INCISION SITE. PHYSICIAN DETERMINED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS POSITIONED OVER A SPINOUS PROCESS AND THAT WAS LEADING TO THE PATIENT DISCOMFORT. SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO MOVE THE IPG TO A MORE COMFORTABLE POSITION FOR THE PATIENT.

  Patient problems: Implant Pain

  MAUDE report 17442074 ↗
• InjuryAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 AND SUBSEQUENTLY REPORTED COMMUNICATION ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IPG IN AN ATTEMPT TO CORRECT THE COMMUNICATION ISSUES (SEE MDR 3015425075-2023-00142). THE PATIENT REPORTED CONTINUING ISSUES AFTER THE IPG REPLACEMENT AND DECIDED TO REMOVE THE SYSTEM. EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17435200 ↗
• InjuryJul 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 FOR UNKNOWN REASON. AT THE TIME OF THE REVISION THE PATIENT WAS ISSUED A REPLACEMENT IMPLANTABLE PULSE GENERATOR AS WELL AS REPLACEMENT EXTERNAL THERAPY DISCS.

  Patient problems: Insufficient Information

  MAUDE report 17421645 ↗
• InjuryJun 22, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022 TO TARGET THE MEDIAL BRANCH NERVE TO TREAT LOWER BACK PAIN. AFTER HAVING BEEN IMPLANTED, THE PATIENT REPORTED REDUCED PAIN LEVELS LEADING TO A MORE ACTIVE LIFESTYLE AND SIGNIFICANT WEIGHT LOSS. AFTER HAVING LOST APPROXIMATELY 75 POUNDS, THERE BECAME AN ISSUE WITH CONNECTIVITY BETWEEN THE NALU IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A POCKET REVISION WAS PERFORMED ON (B)(6) 2023 TO PLACE THE IPG IN A MORE OPTIMAL LOCATION FOR CONNECTIVITY. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17187730 ↗
• InjuryMay 17, 2023Malposition of Device; Malposition of Device

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TARGET THE SUPRASCAPULAR NERVE AND TREAT LEFT SHOULDER PAIN. AFTER HAVING THE SYSTEM ACTIVATED, THE PATIENT REPORTED DIFFICULTIES MAINTAINING CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. THROUGH TROUBLESHOOTING AND INVESTIGATION IT WAS DETERMINED THAT THE PATIENT'S ANATOMY, SPECIFICALLY THE LAXITY IN THE SKIN, WAS ALLOWING EXCESSIVE MOVEMENT OF THE IPG. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO PLACE THE IPG IN A MORE STABLE POSITION TO MAINTAIN COMMUNICATION BETWEEN THE IPG AND THE THERAPY DISCS. NO IMPLANTABLE COMPONENTS WERE REPLACED DURING THE PROCEDURE AND THE PATIENT SUBSEQUENTLY REPORTS BEING SATISFIED WITH THE THERAPY BEING RECEIVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16950939 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022. DURING AN APPOINTMENT WITH THE PHYSICIAN AND NALU REPRESENTATIVE ON (B)(6) 2023 THE PATIENT STATED UNABLE TO FEEL THERAPY FROM THE SYSTEM. SYSTEM WAS EXPLANTED ON (B)(6) 2023 WITH PLAN TO IMPLANT A NEW SYSTEM IN A DIFFERENT LOCATION AT A FUTURE DATE. COMPONENTS WERE NOT RETURNED TO NALU FOR INVESTIGATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16723933 ↗
• InjuryMar 22, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022.APROXIMATELY THREE MONTHS AFTER IMPLANT, THE PATIENT REPORTED DISCOMFORT WITH THE LOCATION OF THE IMPLANT AND REQUESTED A REVISION BE PERFORMED. WHILE THE PATIENT WAS WAITING FOR THE PROCEDURE, CONNECTIVITY ISSUES WERE REPORTED BETWEEN THE IMPLANTED PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISC. ON (B)(6) 2023 A FULL SYSTEM EXPLANT WAS PLANNED. DURING THE EXPLANT SURGERY IT WAS NOTED THAT THE IPG HAD FLIPPED HORIZONTALLY, LIKELY CAUSING THE CONNECTIVITY ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16592737 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A SURGICAL REVISION WAS PERFORMED TO MOVE THE NALU IMPLANTABLE PULSE GENERATOR TO A DIFFERENT LOCATION. PATIENT UNDERWENT SUCCESSFUL WEAR TRIAL WITH THE NALU SYSTEM, HOWEVER THE PATIENT REQUESTED THE PERMANENT IMPLANT BE PLACED IN A DIFFERENT LOCATION THAN THE WEAR TRIAL. AFTER IMPLANT IT WAS DISCOVERED THAT THE LOCATION WAS NOT OPTIMAL FOR THE PATIENT'S ANATOMY AND CAUSED THE EXTERNAL THERAPY DISC TO NOT MAINTAIN ADHESION AND THUS LOSE CONNECTION WITH THE IMPLANTED COMPONENTS. REVISION MOVED THE IMPLANTED COMPONENTS TO A MORE OPTIMAL LOCATION WITHOUT REPLACEMENT OF ANY COMPONENTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16477166 ↗