Nalu Medical, Inc. 72011-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00812537035628), received between Jan 13, 2023 and Sep 30, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (19 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951794 ↗
• InjuryFeb 19, 2026Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE SUPERIOR CLUNEAL NERVE. AFTER USING THE SYSTEM FOR A SHORT TIME, THE LEFT LEAD WAS FOUND TO HAVE MIGRATED AWAY FROM THE INTENDED NERVE TARGET. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2026 TO REPOSITION THE EXISTING LEAD TO PLACE IT BACK AT THE ORIGINAL INTENDED LOCATION. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24393246 ↗
• InjurySep 15, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE MEDIAL BRANCH NERVE AT THE AREA OF L4 VERTEBRAL BODY. AFTER USING THE DEVICE FOR APPROXIMATELY ONE YEAR, THE PATIENT REPORTED TO THE IMPLANTING PHYSICIAN THAT THERE WAS A LOSS OF STIMULATION. XRAY IMAGING WAS PERFORMED AND FOUND THE LEADS HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON 07/28/2025 THE MEDICAL CLINIC NOTIFIED A NALU REPRESENTATIVE THAT THE PATIENT WAS SCHEDULED FOR SURGERY. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS AT THE INTENDED NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23048215 ↗
• InjuryJun 10, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) BEING PLACED IN THE LOWER BACK AREA. AFTER ACTIVATING THE SYSTEM, THE PATIENT NOTED THAT THE SHIFTING BODY POSITIONS WOULD CAUSE DISRUPTIONS IN COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, LEADING TO INTERMITTENT PAIN RELIEF. XRAY IMAGING FOUND THAT, IN ADDITION TO THE COMMUNICATION ISSUES, BOTH IMPLANTED LEADS HAD ALSO MIGRATED AWAY FROM THE OPTIMAL PLACEMENT. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW IPG AT A LESS DYNAMIC LOCATION OF THE BACK AND TO PLACE NEW LEADS BACK AT THE DESIRED LOCATION. SEE MDR 3015425075-2024-00413. AFTER ACTIVATING THE REVISED SYSTEM, THE PATIENT NOTED THAT THE SUPERIOR CLUNEAL LEAD WAS ONLY GETTING COVERAGE IN THE HIP AREA AND NOT ADDRESSING THE LOWER BACK PAIN. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO OPEN UP THE SITE AND PULL THE LEAD TO A MORE MEDIAL POSITION TO BETTER COVER THE LOWER BACK PAIN. NO PRODUCT WAS REMOVED OR REPLACED AND NO NEW IMPLANTS WERE INTRODUCED DURING THIS PROCEDURE. SEE MDR 3015425075-2025-00085. IN (B)(6) 2025 THE PATIENT REPORTED STILL NOT RECEIVIN

  Patient problems: Inadequate Pain Relief

  MAUDE report 22180553 ↗
• InjuryMar 21, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 WITH THE IMPLANTABLE PULSE GENERATOR (IPG) BEING PLACED IN THE LOWER BACK AREA. AFTER ACTIVATING THE SYSTEM, THE PATIENT NOTED THAT THE SHIFTING BODY POSITIONS WOULD CAUSE DISRUPTIONS IN COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISCS, LEADING TO INTERMITTENT PAIN RELIEF. XRAY IMAGING FOUND THAT, IN ADDITION TO THE COMMUNICATION ISSUES, BOTH IMPLANTED LEADS HAD ALSO MIGRATED AWAY FROM THE OPTIMAL PLACEMENT. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO PLACE A NEW IPG AT A LESS DYNAMIC LOCATION OF THE BACK AND TO PLACE NEW LEADS BACK AT THE DESIRED LOCATION. SEE MDR 3015425075-2024-00413. AFTER ACTIVATING THE REVISED SYSTEM, THE PATIENT NOTED THAT THE SUPERIOR CLUNEAL LEAD WAS ONLY GETTING COVERAGE IN THE HIP AREA AND NOT ADDRESSING THE LOWER BACK PAIN. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO OPEN UP THE SITE AND PULL THE LEAD TO A MORE MEDIAL POSITION TO BETTER COVER THE LOWER BACK PAIN. NO PRODUCT WAS REMOVED OR REPLACED AND NO NEW IMPLANTS WERE INTRODUCED DURING THIS PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21667959 ↗
• InjuryFeb 19, 2025Migration; Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. THE SYSTEM WAS IMPLANTED NEAR THE LATERAL SHOULDER WITH THE LEADS TARGETING THE SUPRASCAPULAR NERVE TO TREAT SHOULDER PAIN. DURING THE TRIAL THE PATIENT HAD REPORTED RECEIVING GOOD PAIN RELIEF, HOWEVER THE PATIENT NOTED THAT THE SAME THERAPY WAS NOT BEING FELT WITH THE PERMANENT SYSTEM. IMAGING WAS PERFORMED AND FOUND THAT ONE OF THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET, THUS CAUSING THE INADEQUATE PAIN RELIEF. ON (B)(6) 2025 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD BACK TO THE INTENDED POSITION TO REGAIN THERAPY. NO COMPONENTS WERE REMOVED OR REPLACED DURING THE PROCEDURE AND NO NEW COMPONENTS WERE INTRODUCTED. ALL ORIGINAL SYSTEM COMPONENTS REMAIN IMPLANTED AND IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21417182 ↗
• InjuryFeb 12, 2025Migration; Migration

  ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH A NALU PNS SYSTEM AFTER A SUCCESSFUL TRIAL AND WEAR STUDY. THE NALU SYSTEM WAS SUCCESSFULLY ACTIVATED AND THE PATIENT REPORTED GOOD PAIN RELIEF. ON (B)(6) 2024 THE PATIENT REPORTING FEELING A SENSATION ON (B)(6) 2024 AS IF ONE OF THE LEADS HAD MOVED DOWN AND AWAY FROM THE INITIAL IMPLANT LOCATION. XRAY IMAGING CONFIRMED THE PATIENT CLAIMS OF MIGRATION OF THE LEFT SIDE LEAD. ON (B)(6) 2025 A SURGICAL REVISION WAS PERFORMED TO REPOSITION AND RE-SUTURE THE MIGRATED LEAD. THE PHYSICIAN WAS ABLE TO ACCESS THE LEAD USING A SINGLE INCISION AND REPOSITION AND SUTURE THE LEAD AT THE DESIRED LOCATION. NO IMPLANTED COMPONENTS WERE REMOVED OR REPLACED AND NO NEW COMPONENTS WERE INTRODUCED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21371128 ↗
• InjuryJan 10, 2025Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TARGETING THE MEDIAL BRANCH NERVE TO TREAT LOWER BACK PAIN. AFTER IMPLANTING THE DEVICE THE LEADS MIGRATED TO A MORE SUPERFICIAL LOCATION WHERE THEY WERE VERY CLOSE TO THE SKIN SURFACE. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE ORIGINAL LEADS AND PLACE NEW LEADS BACK IN A MORE APPROPRIATE DEPTH.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21121576 ↗
• InjuryJan 4, 2025Lack of Effect; Lack of Effect

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023 AFTER A SUCCESSFUL TRIAL PHASE WITH NALU. THE PATIENT HAD REPORTED GOOD PAIN RELIEF DURING THE TRIAL AND THEN REPORTED LESS EFFICACY WITH THE PERMANENT SYSTEM. THERE WAS NO EVIDENCE OF ANY SYSTEM OR COMPONENT FAILURE OR MIGRATION. PHYSICIAN REPORTED THAT THE PLACEMENT OF THE LEAD WAS NOT OPTIMAL TO ACHIEVE THE DESIRED COVERAGE. ON (B)(6)2024 A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE EXISTING LEAD ON THE RIGHT SIDE ONLY TO PLACE THE LEAD MORE MEDIAL AND ACHIEVE BETTER PAIN RELIEF COVERAGE FOR THE PATIENT. NO COMPONENTS WERE REMOVED OR INTRODUCED DURING THE PROCEDURE AND ALL ORIGINAL IMPLANTED COMPONENTS REMAIN IN PLACE AND IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21075704 ↗
• InjuryNov 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. THE SYSTEM WAS PLACED SUCH THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IN THE ABDOMINAL AREA AND THE IMPLANTED LEADS WERE TARGETING THE ILIOINGUINAL NERVE TO TREAT PELVIC PAIN. ON (B)(6) 2024 THE FIRM WAS NOTIFIED BY THE MEDICAL CLINIC THAT THE PATIENT WAS SCHEDULED TO HAVE THE NALU SYSTEM EXPLANTED. PER THE PHYSICIAN, THE PATIENT'S IMPLANTED LEAD HAD BECOME EXPOSED AND THE PLAN WAS TO REMOVE THE ENTIRE SYSTEM TO ALLOW HEALING. THE EXPLANT PROCEDURE WAS SCHEDULED TO HAVE TAKEN PLACE ON (B)(6) 2024 HOWEVER, AS OF (B)(6) 2024 THE NALU FIRM HAS NOT BEEN ABLE TO OBTAIN ANY CONFIRMATION THAT THE EXPLANT TOOK PLACE OR WHAT THE PATIENT OUTCOME IS.

  Patient problems: Insufficient Information

  MAUDE report 20803106 ↗
• InjuryOct 8, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS SUCCESSFULLY ACTIVATED AND THE PATIENT WAS RECEIVING THERAPY. SEVERAL MONTHS AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED CHANGE IN THERAPY AND INCONSISTENT RESULTS FROM PREVIOUSLY EFFECTIVE PROGRAMS. XRAY IMAGING FOUND THAT THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INITIAL LOCATION AT THE TIME OF IMPLANT, CAUSING THE INADEQUATE PAIN RELIEF. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO PLACE NEW LEADS BACK AT THE INTENDED NERVE TARGET. DURING THE REVISION, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED AS A PRECAUTION TO AVOID ANY POSSIBILITY OF HANDLING DAMAGE FROM THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20398298 ↗
• InjurySep 24, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE SIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT BILATERAL LOWER BACK PAIN. ON (B)(6) 2024 THE PATIENT CALLED THE NALU PRODUCT SUPPORT LINE TO REPORT THAT THE NALU SYSTEM HAD BEEN EXPLANTED ON (B)(6) 2024 DUE TO INADEQUATE PAIN RELIEF. PER THE PATIENT, THE IMPLANTED LEAD HAD MIGRATED AWAY FROM THE NERVE TARGET, LIKELY CAUSING THE LACK OF PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20295538 ↗
• InjurySep 22, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS SUCESSFULLY ACTIVATED ON (B)(6)2024. IN JULY 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT HAD LOST THERAPY AND TROUBLESHOOTING WAS ATTEMPTED WITHOUT SUCCESS. XRAY IMAGING FOUND THAT THE IMPLANTED SYSTEM HAD SIGNIFICANTLY MIGRATED FROM THE INTENDED LOCATION. SURGICAL REVISION WAS PERFORMED ON (B)(6)2024 TO REPLACE THE MIGRATED LEADS. DURING THE PROCEDURE THE SYSTEM RETURNED IMPEDANCE READINGS INDICATING TWO NON-FUNCTIONING ELECTRODES AND THUS ALSO NECESSITATING REPLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG).

  Patient problems: Inadequate Pain Relief

  MAUDE report 20276183 ↗
• InjurySep 11, 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. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT THE PHYSICIAN HAD EXPLANTED BOTH LEADS EARLIER THAT DAY DUE TO THE PRESENCE OF INFECTION. THE IPG WAS LEFT IN PLACE IN ANTICIPATION OF RE-IMPLANTING THE LEADS AFTER THE INFECTION HAS FULLY CLEARED.

  Patient problems: Unspecified Infection

  MAUDE report 20187118 ↗
• InjurySep 5, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AND HAD THE SYSTEM SUCCESSFULLY ACTIVATED ON (B)(6) 2024. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT FLUOROSCOPY IMAGING WAS PERFORMED ON A RECENT CLINIC VISIT AND HAD CONFIRMED THAT THE IMPLANTED LEADS HAD MIGRATED, LEADING TO POOR PAIN RELIEF FOR THE PATIENT. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE MIGRATED LEAD. DURING THE PROCEDURE, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED DUE ONLY TO THE POTENTIAL FOR SURGICAL HANDLING DAMAGE FROM THE PROCEDURE. THE SECOND LEAD REMAINED IN PLACE AND IS CURRENTLY STILL IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20154070 ↗
• InjuryAug 28, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. AT THE TIME OF SYSTEM ACTIVATION THE PATIENT REPORTED GOOD PAIN RELIEF. SEVERAL WEEKS AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED COMPLETE LOSS OF STIMULATION FROM THE LEFT SIDE LEAD. TROUBLESHOOTING AND IMAGING WAS PERFORMED AND FOUND THAT THE LEFT SIDE LEAD HAD MIGRATED AWAY FROM THE TARGET LOCATION. PATIENT REPORTED RECEIVING GOOD RELIEF ON THE RIGHT SIDE AND REQUESTED TO POSTPONE ANY INTERVENTION IN ORDER TO ASSESS PAIN RELIEF USING ONLY THE RIGHT SIDE LEAD. ON 07/19/2024 THE FIRM RECEIVED COMMUNICATION FROM THE IMPLANTING PHYSICIAN OFFICE NOTIFYING OF A PLANNED REVISION PROCEDURE FOR THIS PATIENT. ON (B)(6) 2024 SURGICAL INTERVENTION TOOK PLACE TO PLACE A NEW LEAD AT THE NERVE TARGET ON THE LEFT SIDE. DURING THE PROCEDURE THE PHYSICIAN ELECTED TO COMPLETELY REMOVE THE EXISTING SYSTEM AND PLACE A NEW ONE OUT OF CAUTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20084796 ↗
• InjuryAug 27, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT LOWER BACK PAIN. AFTER ACTIVATING THE SYSTEM, THE PATIENT LATER REPORTED INADEQUATE PAIN RELIEF. FIELD INVESTIGATION DETERMINE THE MOST LIKELY CAUSE OF THE LACK OF APPROPRIATE THERAPY WAS LEAD MIGRATION. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO PLACE NEW LEADS AT THE DESIRED NERVE TARGET. WHILE REPLACING THE LEADS, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ALSO REPLACED OUT OF CAUTION DUE TO THE POTENTIAL FOR DAMAGE FROM PROCEDURAL HANDLING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20072981 ↗
• InjuryAug 26, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. APROXIMATELY ONE MONTH AFTER IMPLANT, THE PATIENT REPORTED LOSS OF THERAPY AT THE AREA OF PAIN. TROUBLESHOOTING WAS PERFORMED AND XRAY IMAGING CONFIRMED THAT THE IMPLANTED LEAD HAD MIGRATED AWAY FROM THE INTENDED TARGET, CAUSING THE LOSS OF PAIN RELIEF. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO PLACE A NEW LEAD AT THE INTENDED NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20072911 ↗
• InjuryJul 11, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 AND THE SYSTEM WAS ACTIVATED ON (B)(6) 2024. IN (B)(6) 2024 THE PATIENT REPORTED NO LONGER RECEIVING ADEQUATE THERAPY AND IT WAS DISCOVERED THAT THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE TARGETED NERVE LOCATION. ON (B)(6) 2024 THE PHYSICIAN RE-OPENED THE ORIGINAL LEAD INCISION SITE TO PULL THE LEADS BACK AND REPOSITION AT THE DESIRED LOCATION. NO COMPONENTS WERE EXPLANTED OR REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19727409 ↗
• InjuryJun 29, 2024High impedance; High impedance

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022. IN APRIL 2024 THE FIRM RECEIVED A REQUEST TO PERFORM IMPEDANCE CHECK FOR MRI TESTING FOR AN UNRELATED CONDITION. TESTING PERFORMED ON 07MAY2024 RETURNED HIGH IMPEDANCE READINGS ON ONE CONTACT OF ONE IMPLANTED LEAD. ON (B)(6) 2024 A SURGICAL REVISION WAS PERFORMED TO REMOVE THE LEAD WITH IMPEDANCE READINGS AND PLACE A NEW LEAD. ALL OTHER COMPONENTS REMAINED IMPLANTED AND IN USE. THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND IS NOT AVAILABLE FOR EXAMINATION BY THE FIRM. PATIENT REPORTS CONTINUING TO RECEIVE GOOD THERAPY AFTER THE REVISION AND WAS ABLE TO PROCEDE WITH THE REQUESTED MRI TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640136 ↗
• InjuryMar 7, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. IN (B)(6) 2023 AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED PAIN HAD BEEN REDUCED TO 1/10. PATIENT LATER REPORTED LOSS OF THERAPY. TROUBLESHOOTING WAS PERFORMED AND DETERMINED THAT THE IMPLANTED LEADS HAD MIGRATED FROM THE INTENDED NERVE TARGET. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE MIGRATED LEADS. NO OTHER COMPONENTS WERE REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18862355 ↗
• InjuryFeb 28, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023. PATIENT SUBSEQUENTLY REPORTED LOSS OF THERAPY AND THUS INADEQUATE PAIN RELIEF. ON (B)(6)2024 A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE IMPLANTED COMPONENTS DUE TO ONE OF THE LEADS HAVING MIGRATED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18804708 ↗
• InjuryDec 27, 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) 2023 TO TREAT KNEE PAIN. AFTER IMPLANT THE SURGICAL WOUND FULLY HEALED AND THE SYSTEM WAS SUCCESSFULLY ACTIVATED. ON 14OCT2023 THE PATIENT INFORMED A NALU REPRESENTATIVE THAT A SECTION OF THE IMPLANTED LEAD WAS EXPOSED AND PROTRUDING THROUGH THE SKIN. PATIENT WAS ADVISED TO FOLLOW UP WITH THE IMPLANTING PHYSICIAN. IT WAS NOTED AT THAT TIME THAT THE IMPLANTING PHYSICIAN'S PRACTICE HAD CLOSED AND THE PATIENT WOULD NEED TO DECIDE ON A NEW PAIN CONTROL DOCTOR, AND AT THAT TIME THE PATIENT ALSO BECAME SPORADICALLY RESPONSIVE TO COMMUNICATION FROM THE FIRM FOR FOLLOW UP. ON (B)(6) 2023 THE PATIENT INFORMED A NALU REPRESENTATIVE THAT A FULL SYSTEM EXPLANT HAD TAKEN PLACE ON (B)(6) 2023.

  Patient problems: Skin Erosion

  MAUDE report 18406545 ↗
• InjuryAug 2, 2023Migration; Migration

  "PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2022 AND LATER REPORTED THAT THE AREA OF STIMULATION WAS NOT THE AREA OF PAIN. XRAY IMAGING FOUND THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE TARGET NERVE. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE EXISTING LEADS AND POSITION THE REPLACEMENT LEADS AT THE TARGET NERVE FOR PAIN RELIEF THERAPY (SEE MDR 3015425075-2023-00158). PATIENT REPORTED NO PAIN RELIEF AFTER THE INITIAL REVISION, THUS A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2023. LEADS WERE REPLACED WITH TINED LEADS TO MITIGATE POTENTIAL FOR FUTURE MIGRATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17446360 ↗
• InjuryAug 2, 2023Migration; Migration

  PATIENT REPORTS THAT THEY SUSTAINED A FALL AND SUBSEQUENTLY FOUND MIGRATION OF AN IMPLANTED LEAD. PATIENT HAD UNDERGONE A PREVIOUS REVISION DUE TO DISCOMFORT WITH THE PLACEMENT OF THE IMPLANT (SEE MDR 3015425075-2023-00145. RATHER THAN PERFORM A SECOND REVISION ON THE EXISITNG SYSTEM, THE PATIENT AND PHYSICIAN ELECTED TO REMOVE THE SYSTEM TO ALLOW FOR FULL HEALING. THE SYSTEM WAS EXPLANTED IN (B)(6) 2022. EXACT DATE OF EXPLANT IS UNKNOWN AT THIS TIME. PATIENT WAS RE-IMPLANTED WITH THE NALU SYSTEM ON (B)(6) 2023.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17442088 ↗