Nalu Medical, Inc. 71007-US (UDI 00812537036144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00812537036144), received between Apr 27, 2024 and Feb 27, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Intermittent Communication Failure” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Impedance Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER EXTREMITY PAIN. IN (B)(6) 2025 THE PATIENT INQUIRED ABOUT MRI CONDITIONALITY AND WAS ADVISED THAT THE SYSTEM WAS CONDITIONAL PENDING IMPEDANCE CHECKS. IMPEDANCE CHECKS FOUND ALL CONTACTS ON ONE LEAD HAD OPEN CIRCUIT READINGS AND THE MRI WAS UNABLE TO BE COMPLETED AT THAT TIME. THE PATIENT WAS SEEN BY A LOCAL NALU REPRESENTATIVE TO ASSESS THE SYSTEM. THE PATIENT DECLINED TO PERFORM ANY CORRECTIONS AT THAT TIME DUE TO STILL GETTING SOME PAIN RELIEF FROM THE SYSTEM. ON (B)(6) 2026 THE NALU SYSTEM WAS FULLY EXPLANTED SO THAT THE PATIENT CAN MOVE FORWARD WITH THE MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474835 ↗
• InjuryOct 19, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT FOOT PAIN. APPROXIMATELY 1 YEAR AFTER IMPLANTING THE SYSTEM, IN (B)(6) 2025, THE PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED. NO EXPLANATION WAS PROVIDED AS TO WHY THE REQUEST WAS MADE AND THERE WAS NO FURTHER COMMUNICATION FROM THE PATIENT OR PHYSICIAN. ON 10/10/2025 A NALU REPRESENTATIVE REACHED OUT TO THE PHYSICIAN FOR AN UPDATE ON THE PATIENT'S STATUS AND WAS INFORMED THAT THE NALU SYSTEM HAD ALREADY BEEN REMOVED. DATE OF EXPLANT WAS NOT PROVIDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23334091 ↗
• InjuryJul 31, 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 LOWER EXTREMITY PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE PATIENT'S CALF AREA WITH THE IMPLANTED LEADS TARGETING THE COMMON PERONEAL NERVE. ON (B)(6) 2025 THE PATIENT BEGAN A REGIMEN OF ANTIBIOTICS TO TREAT REPORTED FLU-LIKE SYMPTOMS. ON (B)(6) 2025 THE PATIENT NOTIFIED THE FIRM THAT THE SURGICAL INCISION SITE APPEARED TO BE RED AND IRRITATED AND THE PATIENT WAS CONCERNED ABOUT INFECTION. THE PATIENT WAS PRESCRIBED A DIFFERENT ANTIBIOTIC AND INSTRUCTED TO PRESENT AT THE SURGERY CENTER THE FOLLOWING DAY. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE POSSIBLE PRESENCE OF INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22683274 ↗
• InjuryMay 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2023 TO TREAT LOWER EXTREMITY PAIN POST AMPUTATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LATERAL THIGH AREA WITH THE IMPLANTED LEADS TARGETING THE SCIATIC NERVE. THE NALU SYSTEM WAS IMPLANTED TO REPLACE AN EXISTING SYSTEM FROM A DIFFERENT MANUFACTURER. AFTER THE IMPLANT, THE PATIENT CONSISTENTLY REPORTED MINIMAL PAIN RELIEF FROM THE NALU SYSTEM DESPITE MULTIPLE REPROGRAMMING SESSIONS. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO PLACE A SECOND LEAD TO BETTER ACHIEVE PAIN RELIEF. THE IPG THAT WAS ORIGINALLY IMPLANTED DID NOT ACCOMMODATE DUAL LEADS AND THUS THE IPG WAS REMOVED DURING THE PROCEDURE AND A NEW IPG WAS PLACED THAT WOULD ACCOMMODATE DUAL LEADS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22067395 ↗
• InjuryApr 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. AT THE TIME OF THE INITIAL IMPLANT THE PATIENT AGREED TO HAVE THE IMPLANTABLE PULSE GENERATOR (IPG) PLACED IN THE LOWER BACK AREA, WITH THE PLAN TO HAVE A SPOUSE HELP WITH PLACING THE EXTERNAL COMPONENTS. AFTER HAVING THE SYSTEM IMPLANTED THE SPOUSE PASSED AWAY AND THE PATIENT NO LONGER HAS CONSISTENT ASSISTANCE TO PLACE THE EXTERNAL COMPONENTS. THE PATIENT REPORTED STRUGGLING WITH USING THE SYSTEM INDEPENDANTLY AND REQUESTED TO MOVE THE IPG TO A MORE LATERAL POSITION THAT IS EASIER FOR THE PATIENT TO REACH WITHOUT ASSISTANCE. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO MOVE THE EXISTING IPG MORE LATERAL PER THE PATIENT'S REQUEST. NO COMPONENTS WERE REPLACED AND NO NEW COMPONENTS WERE IMPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21915926 ↗
• InjuryJan 2, 2025Wireless Communication Problem; Wireless Communication Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER A SUCCESSFUL TRIAL PHASE. DURING THE TRIAL, THE PATIENT REPORTED REDUCION IN PAIN LEVELS FROM 7/10 DOWN TO 2/10. A PERMANENT SYSTEM WAS IMPLANTED ON (B)(6) 2024 USING ULTRASOUND, PLACING THE IMPLANTABLE PULSE GENERATOR (IPG) IN THE CALF AREA WITH THE LEADS TARGETING THE TIBIAL NERVE TO TREAT LEFT FOOT PAIN. AT THE IMPLANT PROCEDURE, SEVERAL PRELIMINARY PROGRAMS WERE UPLOADED TO THE NALU SYSTEM AND THE PATIENT WAS GIVEN INSTRUCTIONS ON USE OF THE SYSTEM. THE PROGRAMS GIVEN AT THE IMPLANT DATE TYPICALLY REQUIRE REASSESSMENT AND UPDATING AT FUTURE POST-OP FOLLOW-UP APPOINTMENT AND WHEN THE SYSTEM IS ACTIVATED BY A NALU REPRESENTATIVE. AFTER THE IMPLANT PROCEDURE THE PATIENT REPORTED TO THE PHYSICIAN THAT HE WAS UNABLE TO USE THE SYSTEM DUE TO THE REMOTE CONTROL (RC) APPLICATION FAILING TO COMMUNICATE WITH THE NALU SYSTEM AND CONTINUOUSLY REPORTING "SEARCHING, PLEASE WAIT". PATIENT CLAIMED THAT THE SYSTEM DOES NOT WORK AND REQUESTED TO REMOVE IT. PHYSICIAN RECOMMENDED TO HAVE A NALU REPRESENTATIVE ASSESS THE SYSTEM AND PROGRAMS, HOWEVER THE PATIENT ADAMANTLY REFUSED TO ALLOW ANY TROUBLESHOOTING BY

  Patient problems: Inadequate Pain Relief

  MAUDE report 21061036 ↗
• InjuryOct 31, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER EXTREMITY PAIN. AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. COMMUNICATION ISSUES WERE FOUND TO BE DIRECTLY RELATED TO THE PLACEMENT OF THE IPG IN THE CALF AREA. THE EXTERNAL COMPONENTS ARE NOT ABLE TO BE COMFORTABLY OR CONSISTENTLY HELD FLUSH AGAINST THE SKIN DUE TO THE LOCATION OF THE IPG AND THUS THE PATIENT EXPERIENCES FREQUENT DISCONNECTIONS AND LOSS OF THERAPY. THE NALU SYSTEM WAS NOT BEING USED REGULARLY DUE TO THE COMMUNICATION ISSUES. PATIENT ELECTED TO HAVE THE NALU SYSTEM REMOVED WHEN AN MRI WAS ORDERED FOR AN UNRELATED CONDITION. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20578907 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT SHOULDER PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE POSTERIOR SHOULDER AREA WITH THE LEADS TARGETING THE SUPRASCAPULAR NERVE. ON (B)(6) 2024 THE PATIENT REPORTED THAT THE IPG INCISION SITE WAS NOT FULLY CLOSED AND ALSO NOTED THAT A PORTION OF THE IMPLANTED LEAD WAS EXPOSED AND NOT HEALING PROPERLY. PHYSICIAN ELECTED TO REMOVE THE SYSTEM AND ALLOW FULL HEALING TO AVOID ANY RISK OF INFECTION FROM THE SITES REMAINING OPEN. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Impaired Healing

  MAUDE report 20404545 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AND THE SYSTEM WAS ACTIVATED BY A NALU REPRESENTATIVE ON (B)(6) 2024. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE SURGICAL INCISION ON THE CALF AREA HAD BECOME INFECTED AND A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20338005 ↗
• InjuryAug 26, 2024Intermittent Communication Failure; Intermittent Communication Failure

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER UNDERGOING A SUCCESSFUL TRIAL PHASE WITH NALU. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE PATIENT'S CALF AREA WITH THE IMPLANTED LEADS TARGETING THE INFERIOR GENICULAR NERVE TO TREAT INFRAPATELLAR PAIN. DURING THE IMPLANT PROCEDURE, IMPEDANCE AND DEPTH CHECKS RETURNED GOOD RESULTS AND THE SYSTEM WAS ACTIVATED BEFORE THE PATIENT LEFT THE FACILITY. APPROXIMATELY ONE WEEK AFTER IMPLANT AND ACTIVATION, THE PATIENT REPORTED RECEIVING INTERMITTENT THERAPY AND NEEDING TO SECURE THE NALU RELIEF BAND VERY TIGHT TO MAINTAIN CONNECTION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS. PATIENT REPORTED RECEIVING THERAPY ONLY WHEN IN CERTAIN POSITIONS AND LOSING THERAPY UPON CHANGING POSITIONS. AT THE 10 DAY POST-OP VISIT, THE NALU REPRESENTATIVE FOLLOWING THE CASE CONFIRMED THE PATIENT REPORTS OF INTERMITTENT COMMUNICATION. IMAGING WAS PERFORMED AND FOUND THAT THE HEAD OF THE IPG HAD ROTATED AWAY FROM THE SKIN SO THAT THE IPG WAS TILTED, LIKELY CAUSING THE INTERMITTENT COMMUNICATION BETWEEN THE DEVICES. ON (B)(6) 2024 THE PHYSICIAN PERFORMED A SURGICAL PROCEDURE TO IMPLANT A NEW NALU SYSTEM. TH

  Patient problems: Inadequate Pain Relief

  MAUDE report 20069343 ↗
• InjuryJul 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) AT THE POSTERIOR SHOULDER AREA AND THE IMPLANTED LEADS TARGETING THE SUPRASCAPULAR NERVE. AFTER THE IMPLANT WAS COMPLETED, THE PATIENT REPORTED DISCOMFORT WITH THE LOCATION OF THE IPG AND REQUESTED TO HAVE IT MOVED. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO MOVE THE IPG, HOWEVER DURING THE PROCEDURE THE DEVICE SUSTAINED HANDLING DAMAGE AND THE ENTIRE SYSTEM WAS REPLACED.

  Patient problems: Discomfort

  MAUDE report 19727407 ↗
• InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUCCESSFULLY COMPLETED A TRIAL AND WEAR STUDY IN APRIL 2024 AND WAS THEN IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON 02MAY2024 TO TREAT HIP PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA AND THE LEADS TARGETED THE CLUNEAL NERVE. AFTER IMPLANTING THE PERMANENT SYSTEM THE PATIENT REPORTED DISCOMFORT WITH THE LOCATION OF THE IPG AND REQUESTED TO HAVE IT MOVED. A SURGICAL REVISION WAS PERFORMED ON 29MAY2024 TO MOVE THE IPG PER THE PATIENT REQUEST. NO COMPONENTS WERE EXPLANTED OR REPLACED AND NO NEW COMPONENTS WERE IMPLANTED DURING THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 19640134 ↗
• InjuryJun 29, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. ON 22MAR2024 THE PATIENT REPORTED ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS, LEADING TO INTERMITTENT THERAPY AND THUS INADEQUATE PAIN RELIEF. XRAY IMAGING FOUND THAT THE IPG HAD MIGRATED WITHIN THE POCKET, CAUSING THE DISRUPTION IN COMMUNICATION. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW IPG IN A POSITION THAT IS MORE PARALLEL TO THE SKIN TO IMPROVE COMMUNICATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19640133 ↗
• InjuryApr 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT FOOT PAIN. WITHIN SEVERAL WEEKS AFTER THE IMPLANT, THE PATIENT PRESENTED WITH SWELLING IN THE LOWER EXTREMITY AND SUSPECTED CELLULITIS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 DUE TO SUSPECTED INFECTION.

  Patient problems: Cellulitis

  MAUDE report 19198984 ↗