Nalu Medical, Inc. 72002-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812537033624), received between Mar 10, 2022 and Mar 21, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PAIN SYMPTOMS WITH USE OF THE NALU SYSTEM, HOWEVER THE SURGICAL INCISION SITE FAILED TO PROPERLY HEAL DUE TO THE LEAD PRESSING AGAINST THE INCISION. THE PHYSICIAN ATTEMPTED TO CLOSE THE WOUND BUT WAS UNSUCCESSFUL AND EVENTUALLY NOTED VISIBLE SIGNS OF INFECTION AT THE INCISION SITE. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE IPG FROM ITS ORIGINAL POSITION AND PLACE A NEW IPG IN A DIFFERENT POCKED LOCATION AS WELL AS PLACING NEW LEADS THAT WERE POSITIONED TO LAY FLAT UNDER THE SKIN SURFACE AND AVOID PRESSURE ON THE INCISION. SEE MDR 3015425075-2025-00089 . APPROXIMATELY 1 WEEK AFTER THE REVISION, THE NEW SYSTEM WAS ACTIVATED AND THE PATIENT AGAIN REPORTED GOOD PAIN RELIEF. ON (B)(6) 2025 A NALU REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT WAS BEING SCHEDULED TO REMOVE THE NALU SYSTEM. PER THE PATIENT AND SPOUSE, THE INCISION SITE CONTINUES TO DRAIN AND SHOW SIGNS OF INFECTION. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED. NALU PERSONNEL WERE NOT NOTIFIED OF THE PROCEDURE AHEAD OF TIME AND THUS UNABL

  Patient problems: Post Operative Wound Infection

  MAUDE report 21669765 ↗
• InjuryMar 21, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PAIN SYMPTOMS WITH USE OF THE NALU SYSTEM, HOWEVER THE SURGICAL INCISION SITE FAILED TO PROPERLY HEAL DUE TO THE LEAD PRESSING AGAINST THE INCISION. THE PHYSICIAN ATTEMPTED TO CLOSE THE WOUND BUT WAS UNSUCCESSFUL AND EVENTUALLY NOTED VISIBLE SIGNS OF INFECTION AT THE INCISION SITE. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE IPG FROM ITS ORIGINAL POSITION AND PLACE A NEW IPG IN A DIFFERENT POCKED LOCATION AS WELL AS PLACING NEW LEADS THAT WERE POSITIONED TO LAY FLAT UNDER THE SKIN SURFACE AND AVOID PRESSURE ON THE INCISION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21669747 ↗
• InjuryAug 27, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 AFTER PARTICIPATING IN A TRIAL PHASE AND WEAR EXPERIENCE WITH NALU. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA AND THE IMPLANTED LEADS WERE PLACED IN THE AREA OF C2 TO TARGET THE OCCIPITAL NERVE. IN (B)(6) 2024 THE PATIENT REPORTED PAIN LEVELS HAD DECREASED FROM 8/10 DOWN TO 1/10 AND RETURNED TO WORK. IN (B)(6) 2024 THE PATIENT REPORTED LOSS OF THERAPY FROM THE SYSTEM. IMAGING WAS PERFORMED AND FIELD INVESTIGATION CONCLUDED THAT THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 WITH THE INTENTION OF REPOSITIONING THE MIGRATED LEADS. DURING THE PROCEDURE THE IPG WAS DAMAGED AND REQUIRED REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20077033 ↗
• InjuryAug 9, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022 TO TREAT BILATERAL LUMBAR PAIN. APPROXIMATELY ONE WEEK AFTER IMPLANT THE PATIENT REPORTED LOSS OF PAIN RELIEF TO THE RIGHT SIDE ONLY. INVESTIGATION DETERMINED THAT ONE OF THE IMPLANTED LEADS HAD MIGRATED, MAKING TROUBLESHOOTING AND REPROGRAMMING UNSUCCESSFUL. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO RELOCATE ONE LEAD TO ACHIEVE BETTER PAIN COVERAGE FOR THE RIGHT SIDE. NO COMPONENTS WERE REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17494999 ↗
• InjuryAug 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2022. ON (B)(6) 2022 A SURGICAL REVISION WAS PERFORMED TO REPLACE THE IMPLANTED LEADS.

  Patient problems: Insufficient Information

  MAUDE report 17446940 ↗
• InjuryJul 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, PATIENT WAS PREPARED TO BE IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM. DURING THE PROCEDURE IT BECAME APARENT THAT THE PATIENT WAS NOT TOLERATING THE ANESTHESIA WELL AND THE PHYSICIAN MADE THE DETERMINATION TO ABORT THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17421640 ↗
• InjuryMar 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT'S DEVICE WAS EXPLANTED DUE TO SUSPECTED INFECTION AT MIDLINE INCISION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13726688 ↗