Nalu Medical, Inc. 71003-US (UDI 00812537036113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00812537036113), received between Jan 13, 2023 and Jan 24, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. ON (B)(6) 2025 A NALU REPRESENTATIVE WAS NOTIFIED BY A MEDICAL STAFF MEMBER THAT THE PATIENT WAS NOTED TO HAVE DRAINAGE AND REDNESS AT THE SURGICAL SITE AND WAS BEING SCHEDULED FOR AN EXPLANT DUE TO SUSPECTED INFECTION. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS COMPLETED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24173456 ↗
• InjuryApr 27, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. ON (B)(6) 2025 THE NALU SYSTEM WAS FULLY EXPLANTED DUE TO A PLANNED MRI FOR A PRE-EXISTING CONDITION. THE PATIENT WAS UNABLE TO COMPLETE THE MRI WHILE HAVING THE NALU DEVICE IMPLANTED ALONG SIDE A CARDIAC LOOP RECORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915925 ↗
• InjuryJan 23, 2025Device 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 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS SCHEDULED TO HAVE THE NALU SYSTEM REMOVED. PER THE PATIENT, THE SYSTEM IS BEING REMOVED IN ORDER TO MOVE FORWARD WITH SHOULDER REPLACEMENT, BACK SURGERY, AND RELATED MRI NEEDS. THE PLACEMENT OF THE SYSTEM WAS NOT MRI CONDITIONAL AND THUS REQUIRED REMOVAL IN ORDER TO MOVE FORWARD WITH THE ORTHOPEDIC PROCEDURES. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6)2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21226048 ↗
• InjuryJan 17, 2025Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER A SUCCESSFUL TRIAL PHASE WITH NALU. PATIENT HAD REPORTED SIGNIFICANT PAIN RELIEF WITH THE NALU SYSTEM. ON (B)(6) 2024, THE IMPLANTING PHYSICIAN NOTIFIED A NALU REPRESENTATIVE THAT THE PATIENT WAS BEING SCHEDULED FOR A SURGICAL REVISION DUE TO REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. PRIOR TO THE PHYSICIAN NOTIFICATION, THE FIRM HAD BEEN UNAWARE OF ANY PROBLEMS OR CONCERNS WITH THE SYSTEM. ON (B)(6) 2024, THE PATIENT WAS BROUGHT IN TO THE SURGICAL CENTER AND A NALU REPRESENTATIVE ATTEMPTED TO PERFORM AN ASSESSMENT OF THE SYSTEM AND POSSIBLE TROUBLESHOOTING. THE MEDICAL FACILITY DECLINED TO ALLOW ANY CONTACT BETWEEN THE NALU REPRESENTATIVE AND THE PATIENT. THE NALU REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD DISCUSSED THE CASE WITH THE PHYSICIAN AND DECIDED TO EXPLANT THE NALU SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024. NALU REPRESENTATIVES WERE NOT ALLOWED TO BE PRESENT FOR THE PROCEDURE AND THE DEVICE WAS DISCARDED BY THE FACILITY UPON EXPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21185489 ↗
• InjuryOct 17, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED BEING UNABLE TO ATTAIN THE LEVEL OF PAIN RELIEF EXPECTED DESPITE MULTIPLE REPROGRAMMING AND TROUBLESHOOTING ATTEMPTS. ON 09/24/2024 A FULL SYSTEM EXPLANT WAS PERFORMED PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20477982 ↗
• InjuryMay 4, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TARGETING THE CLUNEAL NERVE. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED PERSISTENT ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING WAS PERFORMED AND EXTERNAL COMPONENTS WERE REPLACED, HOWEVER THE ISSUE PERSISTED. XRAY IMAGING CONFIRMED THE IPG HAD MIGRATED WITHIN THE POCKET. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO CREATE A NEW POCKET AND PLACE A NEW IPG IN THAT POCKET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19245038 ↗
• InjuryMay 4, 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 KNEE PAIN. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED DUE TO LEAD MIGRATION. DURING THE PROCEDURE THE LEADS AND THE IMPLANTABLE PULSE GENERATOR (IPG) WERE DAMAGED AND REQUIRED REPLACEMENT (SEE MDR 3015425075-2024-00137). AFTER REPLACING THE COMPONENTS, THE PATIENT DEVELOPED SYMPTOMS OF POSSIBLE INFECTION AT THE INCISION SITE. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19245011 ↗
• InjuryMay 17, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2023, TARGETTING THE CLUNEAL NERVE TO TREAT LOWER BACK PAIN. THE SYSTEM WAS ACTIVATED ON (B)(6) 2023. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED PROBLEMS WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TESTING CONFIRMED THAT THE IPG HAD MIGRATED AFTER BEING IMPLANTED, THUS MAKING COMMUNICATION WITH THE THERAPY DISCS PROBLEMATIC. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023, REPLACING THE IPG. THE ORIGINAL IPG WAS LEFT IN THE EXISTING POCKET WITH A NEW POCKET BEING CREATED FOR THE REPLACEMENT IPG. PATIENT REPORTS THEY ARE RECEIVING SUSTAINED SIGNIFICANT PAIN RELIEF AND THE COMMUNICATION ISSUES HAVE BEEN RESOLVED WITH THE IPG IN THE NEW LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16950935 ↗
• InjuryJan 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED IN ORDER TO CORRECT IMPLANTABLE PULSE GENERATOR AND EXISTING LEAD MIGRATION AS WELL AS PLACE AN ADDITIONAL LEAD.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16156632 ↗