Nalu Medical, Inc. 12007-040-USRecalls & reported problems
Nalu Medical, Inc. · Peripheral Nerve Stimulation Lead (8 contact, 40 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812537035666), received between Sep 29, 2024 and Sep 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2024Migration; Migration
PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOW BACK PAIN. UPON ACTIVATION OF THE SYSTEM ON (B)(6) 2023 THE PATIENT REPORTED THAT PAIN LEVELS HAD BEEN REDUCED TO 2 ON A SCALE OF 1-10. IN (B)(6) 2024 THE PATIENT REPORTED LOSS OF THERAPY DUE TO LEAD MIGRATION AND A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE MIGRATED LEAD ONLY. NO OTHER COMPONENTS WERE REMOVED OR REPLACED DURING THAT PROCEDURE. IN (B)(6) 2024 THE PATIENT AGAIN REPORTED INADEQUATE PAIN RELIEF AND INVESTIGATION FOUND THAT THE LEFT SIDE LEAD HAD AGAIN MIGRATED AWAY FROM THE INTENDED NERVE TARGET. SURGICAL REVISION WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE MIGRATED LEAD AND REPLACE IT WITH A NEW LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 20330367 ↗
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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