Lead Kit (4 Contact, 25cm, Tined) 72006Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00812537037691), received between Feb 19, 2026 and Sep 16, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793679 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Erosion

  MAUDE report 50744649 ↗
• MalfunctionSep 11, 2026Impedance Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50744642 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The patient was implanted with a Nalu Peripheral Nerve Stimulator system on (b)(6) 2025 to treat head pain. The Implantable Pulse Generator (IPG) was placed in the posterior shoulder area with the leads placed at the C2-C3 lateral masses, consistent with a cervical medial branch target.In (b)(6) 2025 the patient contacted a Nalu representative to report loss of stimulation. Assessment of the system confirmed that one lead was not delivering stimulation and had migrated away from the intended nerve target.On (b)(6) 2026 the patient was brought in for surgical revision. During the revision the lead was connected to a known-good IPG and confirmed that the lead itself was malfunctioning. The malfunctioning lead was removed and replaced as well as replacing the original IPG out of caution. See MDR 3015425075-2026-00044.On (b)(6) 2026, approximately 1 month after the revision procedure, the patient reported to the implanting physician that they were experiencing some redness and swelling over the implant revision site. On (b)(6) 2026 the patient was seen by the physician and prescribed antibiotics, although there are no reports of confirmed infection being present at that time. On (b)(6)

  Patient problems: Post Operative Wound Infection; Skin Erosion

  MAUDE report 50024236 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 TO TARGET THE MEDIAL BRANCH NERVE. APPROXIMATELY 6 WEEKS AFTER THE IMPLANT, THE PATIENT REPORTED PAIN AND SWELLING AT THE LOCATION OF A LEAD INSERTION SITE. AFTER 2 TO 3 DAYS, THE LEAD WAS NOTED TO BE ERODING THROUGH THE SKIN. ON (B)(6) 2026 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE SKIN EROSION.

  Patient problems: Skin Erosion

  MAUDE report 25419625 ↗
• InjuryJun 5, 2026Use of Device Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2026 AFTER PARTICIPATING IN A SUCCESSFUL TRIAL PHASE WITH NALU. AFTER HAVING THE PERMANENT SYSTEM IMPLANTED, THE PATIENT REPORTED INADEQUATE COVERAGE TO ADDRESS THE LOCATION OF PAIN. ON (B)(6) 2026, THE 4-CONTACT 25CM LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE REMOVED AND REPLACED WITH 8-CONTACT 40CM LEADS AND IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25403450 ↗
• InjuryApr 6, 2026Intermittent Communication Failure

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT LOWER BACK PAIN. THE SYSTEM WAS PLACED IN THE LOWER BACK AREA WITH THE LEADS TARGETING THE CLUNEAL NERVE. ON (B)(6) 2026, THE PATIENT WAS SEEN IN THE CLINIC FOR REPROGRAMMING AND DURING THE VISIT THE PATIENT REPORTED SOME ISSUES WITH MAINTAINING CONSISTENT CONNECTIVITY BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING REPROGRAMMING, ADJUSTING SYSTEM SETTINGS, REPLACING EXTERNAL DEVICES, AND ADJUSTING POSITION OF EXTERNAL DEVICES; HOWEVER, THE ISSUE PERSISTED. FURTHER ASSESSMENT DETERMINED THAT THE IPG HAD BEEN PLACED WITHIN A SKIN FOLD, CAUSING THE DEVICE TO BE UNSTABLE AND MIGRATE BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY. ON (B)(6) 2026, A SURGICAL REVISION WAS PERFORMED TO MOVE THE IPG TO A NEW POCKET LOCATION THAT WAS MORE SUPERFICIAL AND IN A MORE FLAT LOCATION. DURING THE PROCEDURE THE IPG SUSTAINED SOME HANDLING DAMAGE AND REQUIRED REPLACEMENT. THE ORIGINALLY IMPLANTED LEADS WERE NOT MOVED AND REMAIN IMPLANTED AND IN USE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24794497 ↗
• InjuryApr 1, 2026Migration

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(5) 2025 TO TREAT KNEE PAIN. AFTER ACTIVATING THE SYSTEM AND USING IT FOR A SHORT TIME, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS FOUND TO BE BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL CONNECTIVITY AND ONE OF THE IMPLANTED LEADS HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET. ON (B)(6) 2026 A SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE AFFECTED COMPONENTS. DURING THE PROCEDURE THE LATERAL LEAD AND THE IPG WERE DAMAGED AND REQUIRED REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24754269 ↗
• InjuryFeb 19, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025. DURING A ROUTINE REPROGRAMMING APPOINTMENT N (B)(6) 2025 THE PATIENT REPORTED THAT PAIN SYMPTOMS SEEMED TO BE WORSENING SINCE THE IMPLANT AND THE SYSTEM WAS NOT PROVIDING RELEIF. THE SYSTEM WAS TESTED AND RETURNED NORMAL IMPEDANCE LEVELS AND THE PATIENT REPORTED SENSATION OF STIMULATION AT VERY LOW POWER SETTINGS. IMAGING WAS DONE AND CONFIRMED THE TINED LEADS HAD MIGRATED FORWARD. ON (B)(6) 2026 A SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS AT THE INTENDED NERVE TARGET.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24393247 ↗