Nalu Medical, Inc. 71003-US (UDI 00812537033587)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812537033587), received between Nov 22, 2021 and Sep 22, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026High impedance

  It was reported during an implant procedure there was an unknown problem inserting the lead into the IPG. A second lead was attempted and eventually successful. High impedances were being seen with both leads. Procedure was eventually successful. No reports were received of significant delay to procedure and no harm to patient or staff.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858500 ↗
• InjuryJan 3, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR (PNS)SYSTEM ON (B)(6)2022 TO TREAT SHOULDER PAIN. THE PATIENT HAD A PRE-EXISTING SCS SYSTEM FROM A DIFFERENT MANUFACTURER IN PLACE TO TREAT LOW BACK AND LEG PAIN PRIOR TO IMPLANTING THE NALU PNS SYSTEM, IN (B)(6)2023 THE PATIENT'S SPOUSE CALLED NALU TO INQUIRE ABOUT MRI CONDITIONALITY AND REPORTED THAT THE NALU SYSTEM HAD NOT BEEN IN USE FOR SEVERAL MONTHS DUE TO LOSS OF EFFICACY. SPOUSE WAS ADVISED THAT THE PATIENT WAS NOT CONDITIONAL FOR ANY MRI DUE TO USE OF DUAL SYSTEMS, REGARDLESS OF SYSTEM USE. ON (B)(6)2024 THE NALU SYSTEM WAS EXPLANTED DUE TO MRI COMPATIBILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21074806 ↗
• InjuryDec 29, 2023Impedance Problem; Impedance Problem

  PATIENT WAS IMPLANTED WITH THE NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOW BACK PAIN. PATIENT PRESENTED WITH NEGATIVE IMPEDANCES ON ONE CONTACT OF THE IMPLANTED LEAD WHILE PREPARING FOR A MRI. TROUBLESHOOTING WAS ATTEMPTED AND UNABLE TO RESOLVE THE IMPEDANCE ISSUE. ON (B)(6) 2023 A SURGICAL REVISION WAS PERFORMED TO RESOLVE THE IMPEDANCE ISSUE AND ALLOW THE PATIENT TO MOVE FORWARD WITH THE MRI. DURING THE PROCEDURE, THE IMPLANTED LEAD WAS TESTED AND RETURNED GOOD IMPEDANCES. UPON CONNECTING THE LEAD BACK TO THE IMPLANTABLE PULSE GENERATOR (IPG), NEGATIVE IMPEDANCE READINGS WERE AGAIN OBTAINED. THE IPG WAS REPLACED, WITH THE NEW IPG BEING IMPLANTED INTO A NEW POCKET. ALL IMPEDANCES AND OTHER INTRA-OP TESTING RETURNED GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422651 ↗
• 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) 2022. ON (B)(6) 2023 THE FIRM WAS MADE AWARE THAT THE PATIENT REQUIRED AN MRI FOR AN UNRELATED MEDICAL PROCEDURE AND HAD THE NALU SYSTEM FULLY EXPLANTED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733952 ↗
• 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 SYSTEM ON (B)(6) 2022. APPROXIMATELY ONE YEAR AFTER IMPLANT THE PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED. PATIENT REPORTED NO LONGER NEEDING THE SYSTEM AS THE PAIN LEVELS WERE UNDER CONTROL WITHOUT USE OF THE STIMULATOR. EXPLANT WAS PERFORMED ON (B)(6) 2023 WITH NO REPORTED COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375717 ↗
• InjuryNov 22, 2021Expulsion; Expulsion

  PATIENT REPORTED THAT SHE WAS NOT RECEIVING SUFFICIENT PAIN RELIEF FROM HER NALU PNS SYSTEM. PATIENT REQUESTED AN EXPLANT. BOTH THE IPG AND LEAD WERE EXPLANTED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12855817 ↗