Nalu Medical, Inc. 71005 (UDI 00812537037189)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00812537037189), received between Oct 2, 2024 and Jul 27, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Intermittent Communication Failure” (4 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.

• InjuryJul 27, 2026Insufficient Device Problem Information

  The patient was implanted with a Nalu Spinal Cord Stimulator system on (b)(6) 2023, with the system being replaced in (b)(6) 2025. In (b)(6) 2026, after having used the system for more than a year and a half, the patient reached out to Nalu Product Support to report description of "significant" shocking sensation that was felt only when the Nalu system was active. Per the patient, the sensations began approximately end of (b)(6) 2025, 2 weeks after the system had been replaced. A local Nalu representative met with the patient to assess and reprogram the system during the visit the symptoms reported did not occur, however the patient did note that the symptoms were inconsistent or random. Imaging was completed and found no obvious issues with the implanted components.As no clear cause of the shocking sensation was able to be identified, it was decided that the system would be replaced. On (b)(6) 2026 the IPG was removed and replaced, leaving the original leads in place. The explanted component was not released from the facility for further testing and inspection by Nalu.

  Patient problems: Pain

  MAUDE report 50024263 ↗
• InjuryMar 30, 2026Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TO TREAT LOWER BACK PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED SOME CHALLENGES IN MAINTAINING CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. A NALU REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2026 TO ASSESS THE SYSTEM. IMAGING PERFORMED DURING THE ASSESSMENT CONFIRMED THE IPG HAD MIGRATED WITHIN THE POCKET TO NO LONGER BE SEATED FLAT AND PARALLEL TO THE SKIN SURFACE. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IPG INTO A NEW POCKET SO THAT IT WAS PARALLEL TO THE SKIN TO CORRECT CONNECTIVITY ISSUES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24723461 ↗
• InjuryDec 13, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. ON (B)(6) 2025 THE PATIENT WAS DISCOVERED TO HAVE THE IMPLANTABLE PULSE GENERATOR (IPG) MIGRATED FROM THE ORIGINAL IMPLANTED POSITION. A SURGICAL PROCEDURE WAS SCHEDULED TO CORRECT THE POSITION OF THE IPG; HOWEVER, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. NO FURTHER UPDATES WERE PROVIDED TO THE FIRM REGARDING PLAN OF CARE FOR THIS PATIENT UNTIL A FOLLOW-UP WAS PERFORMED ON (B)(6) 2025 AND THE FIRM BECAME AWARE THAT THE NALU SYSTEM HAD BEEN FULLY EXPLANTED ON AN UNKNOWN DATE AND REPLACED WITH A COMPETITOR SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23797649 ↗
• InjuryDec 8, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. APPROXIMATELY 2-3 MONTHS AFTER THE IMPLANT THE PATIENT REPORTED ONSET OF CONNECTIVITY ISSUES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. IT WAS DETERMINED THAT THE IPG HAD MIGRATED WITHIN THE POCKET TO NO LONGER BE SEATED FLAT AND PARALLEL TO THE SKIN SURFACE, CAUSING THE CONNECTIVITY CHALLENGES. ON (B)(6) 2025, THE IPG WAS REMOVED FROM THE EXISTING POCKET ON THE RIGHT FLANK AREA AND A NEW IPG WAS IMPLANTED IN THE LEFT FLANK AREA.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23739139 ↗
• InjuryOct 23, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2025 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. THE PERMANENT SYSTEM WAS IMPLANTED WITH THE LEADS IN APPROXIMATELY THE SAME LOCATION AS THE TRIAL LEADS. ALTHOUGH THE PATIENT HAD REPORTED APPROXIMATELY 90% PAIN REDUCTION DURING THE TRIAL PHASE, THE PERMANENT SYSTEM WAS REPORTED TO HAVE PROVIDED NO PAIN RELIEF AT ALL. TROUBLESHOOTING IN THE FIELD INCLUDED 5 DIFFERENT SESSIONS OF REPROGRAMMING THE SYSTEM TO OPTIMIZE THERAPY, WITH ONGOING REPORTS OF NO PAIN RELIEF. XRAY IMAGING WAS PERFORMED AND CONFIRMED THAT THE LEADS HAD MIGRATED DOWN A VERTEBRAL LEVEL, THUS WERE NO LONGER STIMULATING THE AREA OF THE PATIENT'S PAIN SYMPTOMS. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE IMPLANTED LEADS AND PLACE AN ANCHOR TO HOLD THE LEADS IN PLACE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23375769 ↗
• InjuryOct 12, 2025Intermittent Communication Failure; Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TARGETING THE THORACIC NERVE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE PATIENT'S LOWER BACK AREA. DURING THE HEALING PROCESS, PRIOR TO THE IMPLANTED COMPONENTS DEVELOPING SCAR TISSUE, THE PATIENT NOTED INCONSISTENT CONNECTIVITY BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS AND IT WAS DETERMINED THAT THE IPG HAD ROTATED WITHIN THE POCKET SO THAT IT WAS NO LONGER FLAT AND PARALLEL TO THE SKIN SURFACE. TROUBLESHOOTING WAS PERFORMED IN THE FIELD TO ENCOURAGE THE IPG TO REMAIN FLAT, HOWEVER WAS NOT SUCCESSFUL. BOTH LEADS LATER RETURNED IMPEDANCE ERRORS IN ADDITION TO THE CONNECTIVITY ISSUES FROM THE IPG MIGRATION. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW IPG IN A NEW POCKET LOCATION AND BOTH MALFUNCTIONING LEADS WERE REPLACED WITH NEW LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23275742 ↗
• InjuryJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU, THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATION SYSTEM ON (B)(6) 2025, TARGETING THE LUMBAR NERVE TO TREAT LOWER BACK AND LOWER EXTREMITY PAIN THE SYSTEM WAS ACTIVATED ON (B)(6) 2025 ON (B)(6) 2025 A NALU REPRESENTATIVE WAS CONTACTED BY THE PATIENT'S DAUGHTER WHO STATED THAT THE PATIENT WAS COMPLAINING OF GROIN PAIN THAT HAD BEGUN AFTER THE NALU SYSTEM WAS IMPLANTED. THE PATIENT'S DAUGHTER REQUESTED RECORDS OF THE IMPLANT PROCEDURE AS THE FAMILY WAS OPTING TO SEEK A SECOND OPINION REGARDING THE NEW PAIN SYMPTOMS. ON (B)(6) 2025 THE PATIENT'S DAUGHTER REPORTED TO A NALU REPRESENTATIVE THAT THE SYSTEM HAD BEEN EXPLANTED THAT DAY DUE TO PAIN AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG).

  Patient problems: Pain

  MAUDE report 22552665 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. DURING A POST-OPERATIVE FOLLOW-UP VISIT AT THE MEDICAL CLINIC, THE PATIENT WAS NOTED TO HAVE VISIBLE SIGNS OF INFECTION WHICH DEVELOPED ALMOST IMMEDIATELY AFTER IMPLANT. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE SUSPECTED INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21982143 ↗
• InjuryOct 2, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. IMMEDIATELY UPON ACTIVATING THE SYSTEM IT WAS NOTED THAT THE COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXTERNAL THERAPY DISCS WAS NOT IDEAL AND WOULD CAUSE INTERMITTENT DISRUPTIONS TO THERAPY FOR THE PATIENT. THE COMMUNICATION ISSUES FAILED TO IMPROVE AFTER ADDITIONAL HEALING TIME AND XRAY IMAGING CONFIRMED THE IPG HAD MIGRATED BEYOND THE RECOMMENDED DEPTH AND HAD ALSO ROTATED TO NO LONGER BE PARALLEL TO THE SKIN SURFACE. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE EXISTING EQUIPMENT TO BRING THE IPG TO THE RECOMMENDED DEPTH AND POSITION FOR OPTIMAL COMMUNICATION. THE SYSTEM WAS SUCCESSFULLY REACTIVATED AND PATIENT HAS REPORTED GETTING GOOD PAIN RELIEF FROM THE SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20356236 ↗