Nalu Medical, Inc. 72006-USRecalls & reported problems
Nalu Medical, Inc. · Lead Kit (4 contact, 25 cm, Tined) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812537031057), received between Nov 23, 2021 and Jul 23, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Unsafe to Use in Environment1
- Fracture1
- Impedance Problem1
- Migration1
Patient problems
- Inadequate Pain Relief2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Impedance Problem; Impedance Problem
PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 AND USED THE SYSTEM FOR APPROXIMATELY 4 YEARS. ON 06/21/2025 AN MRI FACILITY CONTACTED NALU PRODUCT SUPPORT TO INQUIRE ABOUT CONDITIONALITY OF THE SYSTEM. DURING A PRE-MRI CHECK THE NALU SYSTEM WAS DISCOVERED TO HAVE IMPEDANCE ISSUES THAT PREVENTED THE PATIENT FROM MOVING FORWARD WITH THE MRI SCAN. THE NALU PRODUCT SUPPORT TEAM WAS NOTIFIED THAT A FULL SYSTEM EXPLANT TOOK PLACE HOWEVER THE EXACT DATE OF THE EXPLANT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580013 ↗InjuryApr 27, 2024Fracture; Fracture
PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022 TO TREAT SHOULDER PAIN. IN (B)(6) 2023 THE PATIENT REPORTED A LOSS OF THERAPY. IMAGING CONFIRMED A FRACTURE OF ONE IMPLANTED LEAD. ON (B)(6) 2024 A FULL SYSTEM EXPLANT WAS PERFORMED.
Patient problems: Inadequate Pain Relief
MAUDE report 19198983 ↗InjuryJan 10, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2021 AFTER A SUCCESSFUL TRIAL PHASE. AFTER BEING IMPLANTED WITH THE PERMANENT SYSTEM THE PATIENT REPORTED NOT RECEIVING THE SAME PAIN RELIEF AS THE TRIAL AND IS NOT SATISFIED WITH THE RESULTS OF REPROGRAMMING THE SYSTEM. PATIENT REFUSED FURTHER PROGRAMMING AND REQUESTED THE SYSTEM BE REMOVED. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2023.
Patient problems: Inadequate Pain Relief
MAUDE report 18490066 ↗InjuryNov 23, 2021Migration; Migration
PATIENT WAS IMPLANTED ON (B)(6) 2021. PATIENT PERFORMED EXERCISE ACTIVITY IMMEDIATELY AFTER IMPLANT PROCEDURE. FLUOROSCOPY IMAGING SHOWED THE LEAD MIGRATED FORWARD, FURTHER INTO THE POPLITEAL FOSSA. ON (B)(6) 2021 THE PATIENT HAD A REVISION SURGERY TO REMOVE THE ORIGINAL TINED LEAD AND ANOTHER LEAD WITH THE SAME SPECIFICATIONS WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12862850 ↗
Other Stimulator, Peripheral Nerve, Implanted (Pain Relief) devices
- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)429 reports
- Quattrode™ 3169St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A STQ4-RCV-A0Curonix LLC · Stimulator, Peripheral Nerve, Implanted (Pain Relief)8 deaths364 reports
- Nalu Medical, Inc. 71019-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall225 reports
- StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 deaths270 reports
- Nalu Medical, Inc. 71020-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)213 reports
- StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)126 reports
- Nalu Medical, Inc. 71005-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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