Nalu Medical, Inc. 72007-USRecalls & 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 00812537032955), received between Apr 1, 2022 and Apr 7, 2022 — 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.
Most reported problems
Device problems
- Migration2
Patient problems
- Inadequate Pain Relief1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2022Migration; Migration
PATIENT'S LEAD HAS MIGRATED RESULTING IN INADEQUATE PAIN RELIEF. PATIENT UNDERWENT REVISION SURGERY TO CORRECT ISSUE. PATIENT'S SYSTEM HAS YET TO BE PROGRAMMED AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Pain Relief
MAUDE report 14048647 ↗InjuryApr 1, 2022Migration; Migration
PATIENT REPORTED EXPERIENCING PAIN SINCE ON (B)(6) 2021 AND CLAIMS TO NOT RECEIVING ADEQUATE PAIN RELIEF FROM THE SYSTEM. REPROGRAMMING ATTEMPTS WERE NOT ABLE TO RESOLVE ISSUE. IPG APPEARED TO HAVE MIGRATED AND 4-CONTACTS APPEARED TO BE BROKEN AT THE TINES. SYSTEM WAS EXPLANTED ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978179 ↗
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- 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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