Nalu Medical, Inc. 71007-US (UDI 00812537030999)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00812537030999), received between Jun 17, 2020 and Jun 13, 2025 — classified as 35 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. PATIENT HAD EXPRESSED A PREFERRED LOCATION FOR THE IMPLANT, HOWEVER DURING THE PROCEDURE THE PHYSICIAN MADE THE DETERMINATION THAT AN ALTERNATE LOCATION WOULD BE BETTER SUITED TO THE PATIENT'S PHYSICAL ANATOMY. PATIENT CONTACTED NALU TO EXPRESS DISSATISFACTION WITH THE LOCATION OF THE IMPLANT AND REQUESTED TO HAVE IT MOVED TO THE ORIGINALLY REQUESTED LOCATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO MOVE THE IMPLANTABLE PULSE GENERATOR (IPG) TO THE PATIENT'S REQUESTED LOCATION. NO NEW COMPONENTS WERE IMPLANTED AT THE TIME OF THE PROCEDURE. SEE MDR 3015425075-2023-00056. AFTER MOVING THE IPG TO THE PATIENT'S REQUESTED LOCATION, THE PATIENT FOUND THAT THERE WERE ISSUES WITH COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. THE PATIENT EXPRESSED FRUSTRATION AND REQUESTED TO REMOVE THE NALU SYSTEM. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE NALU IPG. THE NALU LEADS REMAIN IMPLANTED AND WERE CONNECTED TO A DEVICE FROM A DIFFERENT MANUFACTURER.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22200124 ↗
• InjuryJun 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT KNEE PAIN. ON (B)(6) 2025, THE FIRM WAS CONTACTED BY AN MRI FACILITY TO REQUEST CONDITIONALITY OF THE NALU SYSTEM. UPON CONFIRMING THAT THE PATIENT WAS NOT CONDITIONAL FOR AN MRI AT THE PLANNED LOCATION, THE FACILITY REPORTED THAT THE PATIENT WAS PLANNING TO EXPLANT THE NALU SYSTEM. A REPRESENTATIVE OF NALU REACHED OUT TO THE IMPLANTING PHYSICIAN, DR. (B)(6), WHO CONFIRMED NO AWARENESS OF ANY ISSUES WITH THE SYSTEM AND NO AWARENESS OF ANY PLANS FOR EXPLANT. THE PATIENT DECLINED COMMUNICATION FROM NALU PERSONNEL UNTIL AFTER THE SYSTEM WAS REMOVED. ON (B)(6) 2025, THE PATIENT NOTIFIED THE NALU REPRESENTATIVE THAT A FULL EXPLANT WAS PERFORMED ON (B)(6) 2025 BY DR. (B)(6).

  Patient problems: Inadequate Pain Relief

  MAUDE report 22147151 ↗
• InjuryMar 12, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE 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 MEDIAL THIGH AREA WITH THE IMPLANTED LEADS TARGETING THE SAPHENOUS NERVE. AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED REDUCTION IN PAIN FROM 8/10 DOWN TO 2/10. AFTER USING THE SYSTEM FOR APPROXIMATELY 6 MONTHS, THE PATIENT REPORTED COMMUNICATION ISSUES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. FIELD INVESTIGATION DETERMINED THAT THE IPG HAD MIGRATED WITHIN THE POCKET SO THAT THE ORIENTATION OF THE COMPONENT PREVENTED COMMUNICATION. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE IPG AND PLACE A NEW ONE THAT WAS SEATED WITH THE CORRECT ORIENTATION. COMMUNICATION ISSUES WERE CONFIRMED TO BE RESOLVED BEFORE COMPLETING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21588173 ↗
• InjuryOct 18, 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) 2021 TO TREAT SHOULDER PAIN. PATIENT REPORTED RECEIVING 90% PAIN RELIEF WITHIN 3 MONTHS OF THE IMPLANT DATE AND AS OF (B)(6) 2024 THE PATIENT REPORTS THAT THE SYSTEM CONTINUES TO BE WORKING WELL WITH NO ISSUES. PATIENT HAS DECIDED TO MOVE FORWARD WITH A TOTAL SHOULDER JOINT REPLACEMENT, WHICH REQUIRES THE NALU SYSTEM TO BE REMOVED PRIOR TO THE PROCEDURE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 IN PREPARATION FOR THE IMPENDING SHOULDER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488104 ↗
• InjuryAug 20, 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 SHOULDER PAIN. ON (B)(6) 2024, A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE PATIENT NEEDING AN MRI AND THE SYSTEM NOT BEING CONDITIONAL FOR THAT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001318 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT FOOT PAIN. IN (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT AND SPOUSE WERE REQUESTING TO HAVE THE SYSTEM EXPLANTED DUE TO INADEQUATE PAIN RELIEF. A REPRESENTATIVE OF THE FIRM REACHED OUT TO THE PATIENT TO OFFER TROUBLESHOOTING. PATIENT AND SPOUSE REPORTED FRUSTRATION WITH THE SYSTEM AND DECLINED TROUBLESHOOTING. A FULL SYSTEM EXPLANT TOOK PLACE ON (B)(6) 2024 PER PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19988876 ↗
• InjuryJul 19, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT SHOULDER PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE UPPER ARM AREA. ON (B)(6) 2023 THE PATIENT CALLED NALU TECH SUPPORT TO REQUEST ASSISTANCE WITH CONNECTIVITY ISSUES BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING WAS DONE OVER THE PHONE AND THE ISSUE APPEARED TO HAVE BEEN RESOLVED AT THE TIME. SUBSEQUENTLY THE PATIENT MET WITH TWO FIRM REPRESENTATIVES FOR FURTHER TROUBLESHOOTING TO ESTABLISH MORE CONSISTENT COMMUNICATION BETWEEN THE IPG AND THE THERAPY DISCS. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19785677 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH TWO NALU PERIPHERAL NERVE STIMULATOR SYSTEMS ON (B)(6) 2024 TO TREAT BILATERAL KNEE PAIN. ON 04APR2024 THE FIRM WAS NOTIFIED THAT THE PHYSICIAN SUSPECTED INFECTION AT BOTH LOWER EXTREMITY SURGICAL INCISION SITES AND WAS PLANNING TO REMOVE BOTH SYSTEMS. ON (B)(6) 2024 BOTH NALU SYSTEMS WERE EXPLANTED DUE TO THE SUSPECTED INFECTIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19274240 ↗
• InjuryApr 13, 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) 2022. IN (B)(6) 2024 THE PATIENT PRESENTED TO THE PHYSICIAN'S OFFICE WITH DISCOMFORT AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH WAS IMPLANTED IN THE MEDIAL BACK AREA, JUST BELOW THE RIBS. THE PHYSICIAN NOTED THAT THE SKIN OVER THE IPG IS VERY THIN BUT WAS NOT OPEN, THERE WAS NO REDNESS, AND NO REPORTS OF FEVERS. PATIENT WAS PLACED ON ANTIBIOTICS AS A PRECAUTION AND INSTRUCTED TO STOP PHYSICAL THERAPY THAT HAD BEEN TAKING PLACE FOR THE SHOULDER AREA. ON (B)(6)2024 THE FIRM WAS NOTIFIED THAT A FULL SYSTEM EXPLANT HAD TAKEN PLACE ON (B)(6)2024 DUE TO THE DISCOMFORT OF THE IPG.

  Patient problems: Discomfort

  MAUDE report 19102515 ↗
• InjuryMar 28, 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) 2023 TO TREAT RIGHT SHOULDER PAIN. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE SURGICAL INCISION HAD FAILED TO HEAL AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPOSED THROUGH THE INCISION SITE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 DUE TO THE INCISION SITE FAILURE TO HEAL. THE FIRM WAS NOT NOTIFIED OF THE PROCEDURE AHEAD OF TIME AND THUS UNABLE TO BE PRESENT.

  Patient problems: Impaired Healing

  MAUDE report 19001446 ↗
• InjuryMar 17, 2024Fracture; Fracture

  PATIENT WAS IMPLANTED, WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. TO TREAT SHOULDER PAIN. PATIENT WAS INITIALLY RECEIVING PAIN RELIEF FROM THE SYSTEM. IN (B)(6) 2023, THE PATIENT REPORTED, SUSTAINING A FALL ON (B)(6) 2023. IN WHICH, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS DIRECTLY STRUCK. THE PATIENT REPORTED, AN IMMEDIATE LOSS OF THERAPY AFTER THE FALL. TROUBLESHOOTING WAS ATTEMPTED AND NOT SUCCESSFUL. XRAY IMAGING DID NOT SHOW ANY MIGRATION OR DAMAGE TO THE IMPLANTED COMPONENTS. ON (B)(6) 2024, THE PATIENT UNDERWENT SURGICAL REVISION TO REPLACE THE IPG AND THE IMPLANTED LEAD. DURING THE REVISION, THERE WAS VISUAL CONFIRMATION OF DAMAGE TO THE SILICONE BOOT, CONNECTING THE LEAD TO THE IPG. AS WELL AS SOME DAMAGE NOTED, TO THE LEAD ITSELF. THE PHYSICIAN AND THE NALU REPRESENTATIVE PRESENT AT THE PROCEDURE NOTED, THAT THE DAMAGE APPEARS TO BE A RESULT OF THE PATIENT FALL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18919264 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH THE NALU PNS SYSTEM ON (B)(6) 2022. ON (B)(6) 2023 A NALU REP WAS NOTIFIED BY THE PHYSICIAN'S OFFICE THAT THE PATIENT HAD AN INFECTION. THE INFECTION FAILED TO RESPOND TO TREATMENT AND ON (B)(6) 2023 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18490067 ↗
• InjuryNov 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT SHOULDER AND LOWER ARM PAIN. PATIENT WAS REPORTED AS RECEIVING PAIN RELIEF FROM THE IMPLANT AND WAS LAST SEEN BY A NALU REPRESENTATIVE FOR REPROGRAMMING IN (B)(6) 2023. IN (B)(6) 2023 THE FIRM WAS MADE AWARE THAT THE PATIENT HAD CONTACTED THE SURGERY CENTER REQUESTING A SYSTEM EXPLANT DUE TO INADEQUATE PAIN RELIEF. PATIENT WAS OFFERED TROUBLESHOOTING AND REPROGRAMMING AND DECLINED ALL OFFERS. ON (B)(6) 2023 A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18188707 ↗
• InjuryOct 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 TO REPLACE AN EXISTING COMPETITOR SYSTEM. PRIOR TO IMPLANT, THE PATIENT HAD BEEN DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME (CRPS). THE IMPLANT WAS IN PLACE FOR APPROXIMATELY ONE YEAR WHEN THE PATIENT REPORTED DISCOMFORT WHEN USING THE SYSTEM FOR MORE THAN ONE HOUR AND EXACERBATION OF THE CRPS. PATIENT DECLINED TROUBLESHOOTING AND REQUESTED TO REMOVE THE SYSTEM. THE NALU SYSTEM WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17981368 ↗
• InjurySep 10, 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) 2023. ON (B)(6) 2023 THE SYSTEM WAS EXPLANTED DUE TO THE IMPLANTABLE PULSE GENERATOR ERODING THROUGH THE PATIENT'S SKIN AT THE INCISION SITE AS WELL AS SUSPECTED INFECTION AT THE SITE OF EROSION.

  Patient problems: Pocket Erosion

  MAUDE report 17717131 ↗
• InjuryAug 22, 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. ON 26JUL2023 A REPRESENTATIVE OF THE FIRM WAS MADE AWARE THAT THE PATIENT WAS REPORTING TENDERNESS AT THE LOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND WAS SCHEDULED FOR SURGICAL INTERVENTION. THE IPG WAS ORIGINALLY IMPLANTED ON THE MEDIAL POSTERIOR CALF. ON (B)(6) 2023 SURGICAL PROCEDURE WAS PERFORMED WHERE A NEW IPG WAS PLACED AT THE ANTEROLATERAL LOWER LEG.

  Patient problems: Discomfort

  MAUDE report 17600558 ↗
• InjuryAug 2, 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 TO TARGET THE CLUNEAL NERVE. AFTER IMPLANT IT WAS DISCOVERED THAT THE PATIENT'S PAIN WAS NOT RELATED TO THE CLUNEAL NERVE AND THUS THE SYSTEM WAS NOT EFFECTIVE IN TREATING THE PAIN SOURCE. MULTIPLE ATTEMPTS WERE MADE TO REPROGRAM THE EXISTING SYSTEM TO TARGET THE ACTUAL PAIN SOURCE WITHOUT SUCCESS. PHYSICIAN AND PATIENT ELECTED TO REMOVE THE SYSTEM, PERFORM MRI, AND REASSESS TO DETERMINE THE SOURCE OF THE PAIN. SYSTEM WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17443738 ↗
• InjuryJul 22, 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 AND REPORTS THAT THE SYSTEM IS WORKING WELL AND PROVIDING PAIN RELIEF SINCE THAT TIME. PATIENT REQUESTED TO HAVE THE SYSTEM EXPLANTED DUE TO THE NEED FOR AN UNRELATED MRI IN THE AREA OF THE IMPLANT. PHYSICIAN REPORTED THAT THE EXPLANT WENT SMOOTH AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375665 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A SUCCESSFUL TRIAL OF THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM IN (B)(6) 2021 AND WAS SUBSEQUENTLY IMPLANTED WITH THE PERMANENT SYSTEM ON (B)(6) 2022. MORE THAN ONE YEAR AFTER THE IMPLANT THE PATIENT REQUESTED REMOVAL OF THE SYSTEM DUE TO LACK OF PAIN RELIEF AND SOME OCCASIONAL DISCOMFORT. THE SYSTEM WAS EXPLANTED ON (B)(6)2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17368710 ↗
• InjuryJun 20, 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) 2023 AND DEVELOPED SIGNS OF INFECTION AT THE SITE OF THE SURGICAL INCISION. PATIENT AND PHYSICIAN ELECTED TO EXPLANT TO SYSTEM TO ALLOW HEALING. EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17164191 ↗
• InjuryJun 15, 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) 2022. PATIENT PRESENTED TO A DIFFERENT PHYSICIAN THAN THE ONE WHO PERFORMED THE IMPLANT AND REQUESTED TO HAVE THE SYSTEM EXPLANTED. EXPLANT WAS PERFORMED ON (B)(6) 2023 WITH NO REPORTS OF COMPLICATIONS DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17140444 ↗
• InjuryMay 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS SUCCESSFULLY IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022, TARGETING THE ULNAR NERVE TO TREAT LOWER ARM AND HAND PAIN. PATIENT SUBSEQUENTLY REPORTED DEVELOPMENT OF A NEW PAIN SYMPTOM ABOVE THE ELBOW IN THE IMPLANTED EXTREMITY. PAIN WAS UNABLE TO BE RELIEVED AFTER SEVERAL ATTEMPTS AT TROUBLESHOOTING AND THUS THE ENTIRE NALU SYSTEM WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17031663 ↗
• InjuryMay 23, 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) 2021, TARGETING THE SAPHENOUS NERVE TO TREAT KNEE PAIN. PATIENT'S ORTHOPEDIC DOCTOR RECOMMENDED A TOTAL KNEE REPLACEMENT AND THE PATIENT AND DOCTOR ELECTED TO EXPLANT THE NALU SYSTEM PRIOR TO PERFORMING THE JOINT REPLACEMENT. THE SYSTEM WAS REMOVED ON (B)(6) 2023 WITH NO REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988965 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. PATIENT HAD EXPRESSED A PREFERRED LOCATION FOR THE IMPLANT, HOWEVER DURING THE PROCEDURE THE PHYSICIAN MADE THE DETERMINATION THAT AN ALTERNATE LOCATION WOULD BE BETTER SUITED TO THE PATIENT'S PHYSICAL ANATOMY. PATIENT CONTACTED NALU TO EXPRESS DISSATISFACTION WITH THE LOCATION OF THE IMPLANT AND REQUESTED TO HAVE IT MOVED TO THE ORIGINALLY REQUESTED LOCATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO MOVE THE IMPLANTABLE PULSE GENERATOR TO THE PATIENT'S REQUESTED LOCATION. NO NEW COMPONENTS WERE IMPLANTED AT THE TIME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844601 ↗
• InjuryApr 26, 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)2022 WITH GOOD PAIN RELIEF. ON (B)(6)2022 THE PATIENT PRESENTED TO THE DOCTOR FOR A FOLLOW UP AND COMPLAINED OF DISCOMFORT AT THE SITE OF THE IMPLANT. PER THE DOCTOR. THE PATIENT WAS EVALUATED AND CAME TO THE CONCLUSION THAT THE PATIENT'S PRE-EXISTING CONNECTIVE TISSUE DISORDER CAUSED THE NALU IMPLANT TO ERODE TOWARD THE SURFACE OF THE SKIN, CAUSING THE PATIENT DISCOMFORT. ON (B)(6) 2023 A SURGICAL REVISION WAS PERFORMED TO PLACE THE IPG AND LEADS IN A MORE OPTIMAL DEPTH FOR THE PATIENT COMFORT. PATIENT HAS SINCE REPORTED THE DISCOMFORT HAS RESOLVED AND HAS RETURNED TO GETTING GOOD PAIN RELIEF.

  Patient problems: Discomfort

  MAUDE report 16821013 ↗