Nalu Medical, Inc. 72007 (UDI 00812537032900)Recalls & reported problems
Nalu Medical, Inc. · Lead Kit (4 contact, 40 cm, Tined) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812537032900), received between Mar 22, 2023 and Sep 15, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Migration2
Patient problems
- Inadequate Pain Relief2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Migration; Migration
THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT KNEE PAIN. ON 08/27/2025 THE FIRM WAS NOTIFIED BY THE PATIENT'S MEDICAL CLINIC THAT A REVISION WAS BEING SCHEDULED DUE TO LEAD MIGRATION. ON (B)(6) 2025 THE ORIGINAL SYSTEM WAS REMOVED AND A NEW SYSTEM WAS IMPLANTED WITH THE LEADS AT THE CORRECT PLACEMENT TO TARGET THE AREA OF PAIN.
Patient problems: Inadequate Pain Relief
MAUDE report 23048213 ↗InjuryMar 22, 2023Migration; Migration
PATIENT WAS IMPLANTED WITH THE NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2022. ON (B)(6) 2023 THE PATIENT REPORTED A FALL AND SUBSEQUENT REDUCTION OF PAIN RELIEF. FLUOROSCOPIC IMAGES CONFIRMED MIGRATION OF THE MEDIAL LEAD. A REPROGRAMMING ATTEMPT WAS MADE ON (B)(6) 2023 TO PROGRAM AROUND THE MIGRATION. ADEQUATE PAIN RELIEF WAS NOT ACHIEVED SO A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2023 TO PLACE A NEW MEDIAL LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 16595769 ↗
Other Stimulator, Peripheral Nerve, Implanted (Pain Relief) devices
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- 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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