Nalu Medical, Inc. 71004-US (UDI 00812537036120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00812537036120), received between Oct 20, 2022 and Sep 29, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Intermittent Communication Failure” (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 53 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Cellulitis; Unspecified Tissue Injury; Wound Infection

  MAUDE report 50939390 ↗
• InjurySep 11, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50744644 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TARGETING THE CLUNEAL NERVE TO TREAT HIP PAIN. AFTER ACTIVATION OF THE SYSTEM, THE PATIENT REPORTED DIFFICULTY MAINTAINING CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, ESPECIALLY WHEN CHANGING BODY POSITIONS. ON (B)(6) 2023 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW IPG IN A MORE OPTIMAL ANATOMICAL POSITION TO REDUCE THE CONNECTIVITY ISSUES RELATED TO CHANGE OF POSITIONING. SEE MDR 3015425075-2023-00318. IN (B)(6) 2026 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND INEFFECTIVE THERAPY FROM THE SYSTEM AND WAS REQUESTING TO HAVE IT REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2026 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24683683 ↗
• InjuryAug 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT UPPER LEG PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE T8-T10 AREA OF THE THORACIC NERVE. APPROXIMATELY MID YEAR IN 2024 THE PATIENT WAS INVOLVED IN AN AUTO ACCIDENT, RESULTING IN AN SACROILIAC JOINT FUSION. INITIALLY AFTER THE AUTO ACCIDENT THE PATIENT WAS EXPERIENCING VERY HIGH LEVELS OF PAIN AND WAS UNABLE TO USE THE NALU SYSTEM. AFTER THE JOINT FUSION, THE PATIENT'S PAIN SYMPTOMS IN THAT ARE WERE REPORTED TO BE SIGNIFICANTLY REDUCED AND THE PATIENT BEGAN TO USE THE NALU SYSTEM AGAIN IN (B)(6) 2024 WITH GOOD RESULTS. IN (B)(6) 2025 THE PATIENT REPORTED SENSATION DESCRIBED AS SHARP JOLTS AT THE LOCATION OF THE NALU IPG. THE SENSATIONS WERE REPORTED TO BE OCCURRING SEVERAL TIMES THROUGHOUT THE DAY. SYMPTOMS WERE REPORTED TO HAVE STARTED APPROXIMATELY (B)(6) 2025 DESPITE RUNNING THE SAME PROGRAMS FOR THE PRIOR 6 MONTHS. PROGRAMMING WAS ADJUSTED TO REDUCE THRESHOLD BUT PATIENT WAS NOT GETTING ADEQUATE THERAPY FROM THE NEW PROGRAMMING AND ELECTED TO RESUME USE OF PREVIOUS PROGRAMS DESPITE THE JOLTING SENSATIONS. IMAGING WAS PERFORME

  Patient problems: Discomfort

  MAUDE report 22768334 ↗
• InjuryAug 4, 2025Intermittent Communication Failure; Intermittent Communication Failure

  ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM AFTER HAVING PARTICIPATED IN A SUCCESSFUL TRIAL PHASE WITH NALU. AFTER USING THE NALU SYSTEM FOR NEARLY A FULL YEAR, THE PATIENT REPORTED ISSUES WITH COMMUNICATION AND WAS SEEN IN THE MEDICAL OFFICE FOR A FOLLOW-UP. THE PLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOTED TO BE NEAR THE AREA ON THE LOWER BACK WHERE THE PATIENT WEARS THEIR PANTS, THUS CAUSING SOME CHALLENGES WITH PLACEMENT OF THE EXTERNAL COMPONENTS AND LIKELY BEING THE CAUSE OF THE COMMUNICATION ISSUES NOTED. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IPG TO A MORE USABLE LOCATION ON THE LOWER BACK.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22709957 ↗
• InjuryJul 21, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN, AROUND (B)(6) 2025, THE PATIENT REPORTED NO LONGER USING THE SYSTEM AND REQUESTED TO REMOVE IT. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2025 PER THE PATIENT'S REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22552662 ↗
• InjuryJul 16, 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) 2024 TO TREAT LOWER EXTREMITY PAIN. THE PATIENT APPEARED TO BE DOING WELL WITH THE THERAPY AND DID NOT REACH OUT TO NALU FOR ANY ISSUES AFTER ACTIVATING THE SYSTEM. ON (B)(6) 2025 AN ACQUAINTANCE OF THE PATIENT INFORMED A NALU REPRESENTATIVE THAT THIS PATIENT NO LONGER HAD THE NALU SYSTEM IMPLANTED. PER THE ACQUAINTANCE, THE LEAD HAD ERODED THROUGH THE SKIN AND DEVELOPED AN INFECTION, LEADING TO EXPLANT. UPON REACHING OUT TO THE PATIENT ON (B)(6) 2025, THE PATIENT NOTED THAT THE SYSTEM HAD BEEN EXPLANTED ON (B)(6) 2024 BUT WAS NOT COMPLETELY SURE OF THAT DATE. THE PATIENT ALSO NOTED THAT THERE WAS NOT ANY INFECTION BUT THAT ONE OF THE LEADS WAS PARTIALLY PROTRUDING THROUGH THE SKIN AND THUS THE EXPLANT WAS PERFORMED.

  Patient problems: Skin Erosion

  MAUDE report 22516733 ↗
• InjuryJul 11, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS INITIALLY IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2021 TO TREAT FOOT PAIN. ALMOST 5 YEARS AFTER THE SYSTEM WAS IMPLANTED, THE PATIENT REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. ON (B)(6) 2025 THE ORIGINAL IPG WAS REMOVED AND A NEW ONE WAS PLACED. THE INITIAL IMPLANT USED A SINGLE LEAD. DURING THE REVISION PROCEDURE THE PHYSICIAN ALSO ADDED A SECOND LEAD TO IMPROVE THERAPY COVERAGE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22479135 ↗
• InjuryJun 13, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT UPPER BACK PAIN. APPROXIMATELY 1 WEEK AFTER ACTIVATING THE SYSTEM THE PATIENT NOTED COMMUNICATION ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. THE ISSUES WERE DETERMINED TO BE RELATED TO DEVICE MIGRATION AND A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO PLACE A NEW IPG HIGHER AND MORE MIDLINE THAN THE ORIGINAL PLACEMENT. SEE MDR 3015425075-2025-00003. AFTER THE REVISION, THE PATIENT REPORTED IMPROVED COMMUNICATION BETWEEN THE COMPONENTS WHILE IN A STATIONARY POSITION, BUT THE DEVICES CONTINUED TO DISCONNECT DURING PATIENT MOVEMENT. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22200118 ↗
• InjuryApr 27, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR (PNS) 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'S DISCOMFORT. SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO MOVE THE IPG TO A MORE COMFORTABLE POSITION FOR THE PATIENT. SEE MDR 3015425075-2023-00145. AFTER THE REVISION PROCEDURE, THE PATIENT REPORTED THAT THEY SUSTAINED A FALL AND SUBSEQUENTLY EXPERIENCED REDUCED EFFICACY OF THE NALU SYSTEM. INVESTIGATION FOUND MIGRATION OF AN IMPLANTED LEAD. RATHER THAN PERFORM A SECOND REVISION ON THE EXISTING SYSTEM, THE PATIENT AND PHYSICIAN ELECTED TO REMOVE THE SYSTEM TO ALLOW FOR FULL HEALING. A FULL SYSTEM EXPLANT WAS PERFORMED IN (B)(6) 2022 (SEE MDR 3015425075-2023-00173) AND THE PATIENT WAS RE-IMPLANTED WITH A NALU PNS SYSTEM ON (B)(6) 2023. THE NEW SYSTEM WAS PLACED SUCH THAT THE IPG IS IN THE LOWER BACK AREA AND THE LEADS TARGETED THE CLUNEAL NERVE. ON (B)(6) 2025, MORE THAN ONE YEAR AFTER THE IMPLANT, THE PATIENT CONTACTED NALU PRODUCT SUPPORT TO REQUEST ASSISTANCE WITH COM

  Patient problems: Inadequate Pain Relief

  MAUDE report 21915929 ↗
• InjuryMar 30, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT PELVIC PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE IMPLANTED LEADS TARGETING THE PUDENDAL NERVE. DURING A POST-OP APPOINTMENT ON (B)(6)2025 THE PATIENT WAS NOTED TO HAVE SOME DIFFICULTY WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS AND ALSO REPORTING SOME PAIN IN ONE LOWER EXTREMITY WHEN THE SYSTEM IS ACTIVE. TESTING AND TROUBLESHOOTING IN THE FIELD FOUND THAT THE IPG APPEARS TO BE PARALLEL TO THE SKIN SURFACE BUT SLIGHTLY BEYOND THE RECOMMENDED DEPTH. ON (B)(6)2025 A SURGICAL REVISION TOOK PLACE TO MOVE THE EXISTING IPG TO A MORE SUPERFICIAL POCKET LOCATION SLIGHTLY SUPERIOR TO THE INITIAL PLACEMENT. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21728555 ↗
• InjuryMar 23, 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)2024 AND AS OF (B)(6) 2024 THE SURGICAL INCISION SITES WERE REPORTED TO HAVE FAILED TO CLOSE AND HEAL AS EXPECTED. AN EXPLANT WAS SCHEDULED TO TAKE PLACE ON (B)(6)2024 DUE TO THE FAILURE TO HEAL, HOWEVER DURING THE PRE-OP ASSESSMENT THE SITES WERE REPORTED TO HAVE FULLY CLOSED AND THE EXPLANT DID NOT TAKE PLACE AND THE PHYSICIAN STATED THE PATIENT WOULD CONTINUE TO BE MONITORED. ON (B)(6)2025 A NALU REPRESENTATIVE WAS NOTIFIED BY THE PHYSICIAN'S OFFICE THAT THIS PATIENT HAD UNDERGONE AN EXPLANT ON (B)(6)2025 DUE TO ONGOING ISSUES WITH HEALING.

  Patient problems: Impaired Healing

  MAUDE report 21673428 ↗
• InjuryMar 22, 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 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE TO TREAT LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LATERAL THIGH AREA OF THE LEFT LEG, WITH THE LEADS TARGETING THE SCIATIC NERVE. THE SYSTEM WAS SUCCESSFULLY ACTIVATED WITH NO ISSUES. ON (B)(6)2025 A NALU REPRESENTATIVE SPOKE WITH THE PATIENT ABOUT SCHEDULING A VISIT FOR REPROGRAMMING. THE PATIENT DID NOT REPORT ANY CONCERNS DURING THAT CONVERSATION. ON (B)(6)2025 THE FIRM WAS NOTIFIED THAT THE PATIENT ARRIVED AT A LOCAL EMERGENCY DEPARTMENT (ED) VIA AMBULANCE ON (B)(6)2025 WITH COMPLAINTS OF EXTREME PAIN IN THE LEFT UPPER LEG. INTAKE ASSESSMENT AT THE ED IDENTIFIED A SOFTBALL SIZE ABSCESS ON THE UPPER THIGH NEAR THE LOCATION OF THE NALU INSERTION SITE.THE ABSCESS WAS CONFIRMED VIA CT SCAN. THE IMPLANTING PHYSICIAN WAS CONTACTED AND AGREED WITH THE ED PHYSICIAN THAT THE NALU SYSTEM WOULD BE REMOVED. THE PATIENT WAS ADMITTED TO THE ACUTE FACILITY FOR IV ANTIBIOTICS AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6)2025. THE INCISIONS WERE IRRIGATED UPON EXPLANT AND THE PATIENT REMAINED ON ANTIBIOTICS.

  Patient problems: Abscess

  MAUDE report 21671728 ↗
• InjuryFeb 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER PARTICIPATING IN A TRIAL PHASE WITH A DIFFERENT MANUFACTURER. ON (B)(6) 2024 THE PATIENT CALLED THE NALU TECHNICAL SUPPORT LINE TO REPORT FEELINGS OF STABBING TYPE PAIN WITHIN APPROXIMATELY 2 INCHES OF THE LOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT REPORTED FEELING THE SENSATION ONLY WHILE THE SYSTEM WAS ON AND DELIVERING THERAPY AND NOTED THAT THE SENSATION DECREASED WHEN THE AMPLITUDE OF THE DEVICE WAS DECREASED. XRAY IMAGING WAS DONE AND SUGGESTED AN ISSUE WITH THE LEGS WHERE THE IMPLANTED LEADS CONNECT TO THE IPG. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IPG. DURING THE PROCEDURE, A NALU REPRESENTATIVE PRESENT VISUALLY CONFIRMED THAT ONE LEG OF THE IPG APPEARED TO BE FRACTURED. MOVING FUNCTIONAL LEADS BETWEEN THE TWO IPG LEGS CONFIRMED THAT THE IPG LEG WAS DAMAGED AND REQUIRED REPLACEMENT.

  Patient problems: Pain

  MAUDE report 21309558 ↗
• InjuryJan 18, 2025Malposition of Device; Malposition of Device

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT LOWER BACK PAIN. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO MOVE THE IMPLANTABLE PULSE GENERATOR (IPG) TO A MORE LATERAL POSITION ON THE LOWER BACK, MAKING THE LOCATION MORE ACCESSIBLE FOR THE PATIENT TO PLACE THE THERAPY DISCS. THE EXISTING IMPLANTED LEADS REMAINED IN USE WITH THE ADDITION OF LEAD EXTENSIONS IN ORDER TO CONNECT TO THE IPG AT IT'S NEW LOCATION. THE EXISTING IPG REMAINED IN USE AFTER BEING REPOSITIONED. ON (B)(6) 2024 A NALU REPRESENTATIVE WAS INFORMED BY THE PHYSICIAN THAT THE PATIENT HAD STATD THE NALU SYSTEM WAS NOT EFFECTIVE AND REQUESTED TO REMOVE IT. PER THE PHYSICIAN, THE NALU SYSTEM WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21187580 ↗
• InjuryJan 13, 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) 2023 TO TREAT LOWER ARM PAIN. THE PATIENT PARTICIPATED IN A SUCCESSFUL TRIAL WITH NALU AND REPORTED PAIN REDUCTION WITH THE TRIAL SYSTEM. THE PERMANENT IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE CERVICAL NERVE AT THE T5 VICINITY. THE SYSTEM WAS SUCCESSFULLY ACTIVATED AND APROXIMATELY ONE WEEK AFTER ACTIVATION THE PATIENT REPORTED HAVING EXPERIENCED A SEIZURE. PATIENT PERCEPTION WAS THAT THE SEIZURE MAY HAVE SOMEHOW BEEN RELATED TO THE NALU IMPLANT DESPITE HAVING NO PRIOR ISSUES WITH THE TRIAL SYSTEM OR AT THE TIME OF THE SYSTEM ACTIVATION. PATIENT DECLINED TO USE THE SYSTEM MOVING FORWARD AND REQUESTED TO HAVE IT EXPLANTED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT'S REQUEST.

  Patient problems: Convulsion/Seizure

  MAUDE report 21136643 ↗
• 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 AFTER HAVING COMPLETED A SUCCESSFUL TRIAL AND WEAR STUDY WITH NALU. APPROXIMATELY 6 WEEKS AFTER ACTIVATING THE SYSTEM THE FIRM WAS NOTIFIED THAT THE SURGICAL WOUND WAS NOT HEALING AS EXPECTED AND INFECTION WAS SUSPECTED. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT REQUEST.

  Patient problems: Impaired Healing

  MAUDE report 20814878 ↗
• InjuryNov 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS ACTIVATED ON (B)(6) 2024 THE PATIENT NOTIFIED A NALU REPRESENTATIVE OF NEW ONSET OF PAIN SYMPTOMS IN THE LOWER BACK AREA. PER THE PATIENT, SYMPTOMS BEGAN ON THE DATE OF IMPLANT AND PERSISTED REGARDLESS OF IF THE NALU SYSTEM WAS TURNED ON OR NOT. REPROGRAMMING OF THE NALU SYSTEM WAS PERFORMED ON (B)(6) 2024 AND THE PATIENT INDICATED THAT AN EXPLANT WOULD BE PLANNED FOR (B)(6) 2024 DUE TO THE NEW PAIN SYMPTOMS. ON (B)(6) 2024 THE PATIENT NOTIFIED THE MEDICAL FACILITY THAT HE WOULD NOT BE MOVING FORWARD WITH THE PLANNED EXPLANT AND WOULD ALLOW FOR POST-SURGICAL HEALING AND FURTHER PROGRAMMING AND TROUBLESHOOTING WITH NALU BEFORE MAKING ANY PLANS FOR FURTHER INTERVENTIONS. PATIENT WAS SEEN SEVERAL TIMES FOR EDUCATION ON THE SYSTEM AND ADJUSTMENT OF PROGRAMMING. PATIENT REPORTED A NEW ONSET OF PAIN SYMPTOMS ON THE FRONT OF THE HIP AND LEG AS WELL AS ONGOING PAIN IN THE LOWER BACK AND BACK OF THE LEG. PATIENT COMMUNICATED SEVERAL TIMES WITH THE LOCAL NALU REPRESENTATIVE THAT REQUESTS WERE MADE FOR THE MEDICAL CLINIC TO ADD OR INCREASE PAIN MEDICATION AFTER THE NALU

  Patient problems: Pain

  MAUDE report 20767582 ↗
• InjuryNov 21, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023. AFTER IMPLANTING THE NALU SYSTEM THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT AND FOUND THAT THE SYSTEM WAS NO LONGER COMMUNICATING CONSISTENTLY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. ON (B)(6)2024 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IPG TO A POSITION APROXIMATELY 3 INCHES HIGHER ON THE PATIENT'S LOWER BACK. NO IMPLANTED COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE, ONLY REPOSITION OF EXISTING COMPONENTS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20742101 ↗
• InjuryNov 6, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO REPLACE A PREVIOUSLY IMPLANTED DEVICE FROM A DIFFERENT MANUFACTURER. THE NALU IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED AT THE ANTERIOR CHEST WALL, INFRACLAVICULAR LOCATION. THE PATIENT REPORTED THAT SWELLING WAS PRESENT AT THE IMPLANT SITE PRIOR TO PLACING THE NALU SYSTEM, AND SWELLING PERSISTED FOR SEVERAL WEEKS AFTER THE IMPLANT OF THE NALU SYSTEM, DELAYING ACTIVATION. AFTER ACTIVATING THE SYSTEM ON (B)(6)2024 IT WAS DISCOVERED THAT THE IPG HAD MIGRATED WITHIN THE POCKET, CAUSING DIFFICULTY IN COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS AND SUBSEQUENT INCONSISTENT THERAPY FOR THE PATIENT. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO MOVE THE EXISTING IPG FROM A VERTICAL ORIENTATION TO A HORIZONTAL ORIENTATION IN ATTEMPT TO PROVIDE A MORE STABLE LOCATION. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20621385 ↗
• InjuryOct 8, 2024Lack of Effect; Lack of Effect

  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 LEADS TARGETING THE CLUNEAL NERVE. IN MAY 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS EXPERIENCING WHAT WAS DESCRIBED AS SUDDEN DRAINAGE FROM THE IPG INCISION SITE ON THE LOW BACK. PER THE PHYSICIAN, THERE WAS A POSSIBILITY OF INFECTION AND PHYSICIAN WAS CONCERNED THAT THE IMPLANT HAD BEEN SOMEHOW COMPROMISED. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE EXISTING NALU SYSTEM, IRRIGATE AND CLEAN THE INCISION AREA, AND PLACE A NEW NALU SYSTEM (SEE MDR 3015425075-2024-00220). AFTER THE SYSTEM WAS REPLACED, THE PATIENT REPORTED INADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING AND TROUBLESHOOTING ATTEMPTS. PHYSICIAN INFORMED THE FIRM THAT CT SCANS SHOWED WHAT APPEAR TO BE MECHANICAL ISSUES WITH THE PATIENT'S PHYSIOLOGY, WHICH WOULD REQUIRE REMOVAL OF THE NALU SYSTEM TO ADDRESS. ON (B)(6) 2024 THE NALU SYSTEM WAS FULLY EXPLANTED TO ALLOW THE PATIENT TO ADDRESS OTHER PHYSICAL ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20398219 ↗
• InjurySep 22, 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. PATIENT REPORTED GOOD PAIN RELIEF FROM THE NALU IMPLANT, HOWEVER DEVELOPED AN INFECTION AT THE IMPLANTED LEAD SITE. DURING A WOUND CARE VISIT ON (B)(6) 2024 IT WAS DETERMINED THAT THE SYSTEM WOULD NEED TO BE REMOVED TO ALLOW HEALING. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20276188 ↗
• InjurySep 22, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT SHOULDER PAIN. THE SYSTEM WAS SUCCESSFULLY ACTIVATED ON (B)(6) 2024 AND PATIENT REPORTED RECEIVING PAIN RELIEF. AFTER ACTIVATING THE SYSTEM THE PATIENT GAINED A SIGNIFICANT AMOUNT OF WEIGHT AND SUBSEQUENTLY HAD TROUBLE WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A SURGICAL REVISION WAS PERFORMED ON (B)(6)2024 TO REPOSITION THE IPG TO A MORE SUPERFICIAL POSITION TO ACCOMODATE THE CHANGE IN WEIGHT. NO COMPONENTS WERE REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20276147 ↗
• InjurySep 11, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED SOME ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING WAS PERFORMED, INCLUDING REPLACING THE EXTERNAL DEVICE. ULTRASOUND AND FLOUROSCOPIC IMAGING DETERMINED THAT THE IPG HAD MIGRATED WITHIN THE POCKET SO THAT THE DEVICE NO LONGER SAT PARALLEL TO THE SKIN SURFACE. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO REPOSITION THE EXISTING COMPONENTS TO SIT PARALLEL TO THE SKIN SURFACE AND WITHIN THE RECOMMENDED DEPTH FOR OPTIMAL COMMUNICATION. NO NEW COMPONENTS WERE INTRODUCED AND ALL ORIGINAL COMPONENTS REMAIN IMPLANTED AND IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20187128 ↗
• InjuryAug 23, 2024Unintended Collision; Unintended Collision

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR ON (B)(6) 2023 TO TREAT LOWER BACK AND LEG PAIN. PATIENT REPORTED RECEIVING GOOD PAIN RELIEF AFTER ACTIVATING THE IMPLANT. AROUND (B)(6) 2023 THE PATIENT SUSTAINED A FALL IN WHICH THE IMPLANT SITE WAS DIRECTLY STRUCK, AND THE PATIENT SUBSEQUENTLY REPORTED LOSS OF THERAPY. IMAGING CONFIRMED THE IMPLANTABLE PULSE GENERATOR (IPG) AND BOTH LEADS HAD MIGRATED AFTER THE FALL. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 IN WHICH THE EXISTING SYSTEM WAS REMOVED, AND A NEW SYSTEM WAS IMPLANTED BACK INTO THE DESIRED LOCATION TO RESTORE THERAPY (SEE MDR 3015425075-2024-00017).ON (B)(6) 2024 THE PATIENT REPORTED HAVING SUSTAINED A FALL FROM A VEHICLE. AFTER THE FALL THE PATIENT REPORTED PAIN OR DISCOMFORT AT THE SITE OF THE IPG AND SUBSEQUENT XRAY IMAGING ALSO APPEARED TO SHOW THAT THE IMPANTED LEADS FROM THE NALU SYSTEM HAD AGAIN SHIFTED AWAY FROM THE NERVE TARGET. SURGICAL INTERVENTION WAS INITIATED ON (B)(6) 2024 TO REPOSITION THE LEADS, HOWEVER UPON BEGINING THE PROCEDURE THE PHYSICIAN AND NALU REPRESENTATIVE FOUND THAT THE LEADS HAD NOT MOVED AS PREVIOUSLY THOUGHT. THE EXISTING IPG WAS REMOVED FROM THE ORIGINAL POCKET ON THE

  Patient problems: Discomfort

  MAUDE report 20045184 ↗