Nalu Medical, Inc. 72001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812537037202), received between Oct 12, 2025 and Sep 13, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain; Scar Tissue

  MAUDE report 50746885 ↗
• InjuryApr 6, 2026Malposition of Device

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT NECK PAIN. AT THE TIME OF IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH THE LEADS TARGETING THE CERVICAL NERVE. DURING A FOLLOW-UP CLINIC VISIT IN (B)(6) 2026, A NALU REPRESENTATIVE WAS MADE AWARE THAT ONE OF THE IMPLANTED LEADS HAD ERODED THROUGH THE SKIN AND A REVISION WAS BEING SCHEDULED. ON (B)(6) 2026 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE EXISTING LEAD DEEPER BENEATH THE SKIN SURFACE. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND ALL ORIGINAL COMPONENTS REMAIN IMPLANTED AND IN USE.

  Patient problems: Skin Erosion

  MAUDE report 24794495 ↗
• InjuryMar 30, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TO TREAT SHOULDER PAIN. THE IMPLANTABLE PULSE GENERATOR WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH THE LEADS TARGETING THE SUPRASCAPULAR NERVE. IN MID (B)(6) 2026 THE PATIENT REPORTED INCREASED PAIN WHEN THE NALU SYSTEM WAS ACTIVE. PATIENT WAS INSTRUCTED TO TURN OFF THE SYSTEM AT THAT TIME. IMAGINE CONFIRMED THE IMPLANTED LEAD HAD MIGRATED, LIKELY CAUSING THE INCREASED PAIN WITH ACTIVE STIMULATION. ON (B)(6) /2026 THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM TO PREPARE FOR A REVISION PROCEDURE TO REPOSITION THE LEAD. WHILE DRAPING THE PATIENT THE PHYSICIAN NOTED THAT THE IMPLANT INCISION SITE WAS RED AND HAD PURULENT DRAINAGE. UPON ASSESSING THE SITE THE DECISION WAS MADE TO FULLY EXPLANT THE SYSTEM, IRRIGATE WITH ANTIBIOTICS, AND ALLOW THE SITE TO HEAL.

  Patient problems: Implant Pain

  MAUDE report 24722326 ↗
• InjuryFeb 25, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS IMPLANTED SUCH THAT THE LEADS WERE TARGETING THE LUMBAR NERVE IN APPROXIMATELY T8/T9 LOCATION. AFTER USING THE SYSTEM FOR SOME TIME IT WAS DISCOVERED THAT THE LEADS HAD MIGRATED AWAY FROM THE ORIGINAL IMPLANT LOCATION. ON (B)(6) 2026 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE LEADS. DURING THE PROCEDURE THE LEADS APPEARED TO SUSTAIN SOME HANDLING DAMAGE AND ULTIMATELY WERE REPLACED WITH NEW LEADS THAT WERE POSITIONED AT THE TOP OF T7 LOCATION TO PROVIDE IMPROVED PAIN RELIEF FOR THE PATIENT. DURING THE REVISION PROCEDURE THE SYSTEM RETURNED IMPEDANCE ERRORS BOTH BEFORE AND AFTER REPLACING THE LEADS. INTRODUCING A NEW IMPLANTABLE PULSE GENERATOR (IPG) REMOVED THE IMPEDANCE ERRORS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24442141 ↗
• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT BACK PAIN, WITH THE IMPLANTED LEADS TARGETING THE CLUNEAL NERVES. ON (B)(6) 2025 THE PATIENT WAS NOTED TO HAVE ONE OF THE LEADS BEGINING TO ERODE THROUGH THE SKIN. ORAL ANTIBIOTICS WERE PRESCRIBED AT THAT TIME AND THE WOUND WAS DRESSED. ON (B)(6) 2025 THE PATIENT WAS TAKEN INTO SURGERY TO REPOSITION THE EXPOSED LEAD AND SUTURE IT DOWN TO AVOID ANY FURTHER MOVEMENT.

  Patient problems: Erosion

  MAUDE report 23334090 ↗
• InjuryOct 12, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2025 TO TREAT BACK PAIN. THE SYSTEM WAS ACTIVATED ON (B)(6)2025 WITH NO COMPLAINTS. APPROXIMATELY 2 WEEKS AFTER ACTIVATION THE PATIENT WAS SEEN IN THE CLINIC FOR REPROGRAMMING TO OPTIMIZE THERAPY DUE TO REDUCED RESPONSE TO THE STIMULATION. OVER THE COURSE OF THE FOLLOWING MONTH THE PATIENT REPORTED ONGOING REDUCED EFFICACY OF THE SYSTEM DESPITE MULTIPLE REPROGRAMMING SESSIONS, EVENTUALLY REPORTING NO THERAPY BEING RECEIVED AT ALL. XRAY IMAGING WAS PERFORMED ON (B)(6)2025 AND CONFIRMED ONE LEAD HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET, LEADING TO THE LOSS OF THERAPY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6)2025 TO REMOVE THE MIGRATED LEAD AND PLACE A NEW LEAD BACK AT THE NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23275718 ↗