Nalu Medical, Inc. 72012-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812537035642), received between Feb 23, 2023 and Dec 26, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT HEAD PAIN. IN (B)(6) 2024 THE PATIENT REPORTED CHANGES IN THE EFFECTIVENESS OF THERAPY. XRAY IMAGING SUGGESTED THAT BOTH OF THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INITIAL PLACEMENT. ON (B)(6)2024 A SURGICAL REVISION WAS PERFORMED IN WHICH IT WAS CONFIRMED THAT ONLY ONE OF THE LEADS HAD MIGRATED AND REQUIRED REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21024100 ↗
• InjuryApr 4, 2024Migration; Migration

  ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM TARGETING THE OCCIPITAL NERVE TO TREAT HEAD PAIN AND HEADACHES. PATIENT HAD PREVIOUSLY COMPLETED A TRIAL PHASE WITH THE NALU SYSTEM AND HAD REPORTED PAIN WAS REDUCED FROM 7/10 TO 1/10 DURING THE TRIAL. AFTER COMPLETING THE PERMANENT SYSTEM IMPLANT AND INITIAL ACTIVATION OF THE SYSTEM, THE PATIENT REPORTED INADQUATE PAIN RELIEF AND DISCOMFORT WITH THE PLACEMENT OF THE IMPLANTED LEADS. XRAY IMAGING FOUND ONE OF THE IMPLANTED LEADS HAD MIGRATED. PATIENT WAS OFFERED REPROGRAMMING TO ATTEMPT TO ATTAIN ADEQUATE PAIN RELIEF WITH THE LEAD AS-IS AND PATIENT REFUSED ALL ATTEMPTS AT TROUBLESHOOTING. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT REQUEST.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19047825 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021. AFTER IMPLANT THE PATIENT EXPERIENCED LOSS OF THERAPY WHICH WAS DETERMINED TO BE DUE TO MIGRATION OF THE IMPLANTED LEADS. FIELD OBSERVATIONS CONCLUDED THE ANCHORING TECHNIQUE CONTRIBUTED TO LEAD MIGRATION AND SUBSEQUENT LOSS OF PAIN RELIEF THERAPY. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO REPOSITION THE MIGRATED LEADS. DURING THE PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) AND IMPLANTED LEADS WERE DAMAGED AND REQUIRED REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17443743 ↗
• InjuryMar 17, 2023Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022. PATIENT SUBSEQUENTLY REPORTED LOSS OF THERAPY WHICH WAS DETERMINED TO BE DUE TO AXIAL LEAD MIGRATION. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2023 TO MOVE THE MIGRATED LEAD TO A MORE OPTIMAL LOCATION. NO COMPONENTS WERE REMOVED AND NO NEW COMPONENTS WERE IMPLANTED. PATIENT REPORTS RECEIVING STIMULATION TO THE DESIRED LOCATION AFTER THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16565205 ↗
• InjuryFeb 23, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON 24JAN2023 SURGICAL REVISION WAS PERFORMED TO INTRODUCE A SECONDARY LEAD IN ORDER TO PROVIDE ADDITIONAL PAIN RELIEF COVERAGE. NO REPORTS OF DEVICE MALFUNCTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16433606 ↗