Nalu Medical, Inc. 71019-US (UDI 00812537035598)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812537035598), received between Jul 6, 2022 and Aug 23, 2023 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2024Class IIOpen, Classified

   Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.

   Z-2257-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME TO NALU AFTER A TRIAL IMPLANT FROM A DIFFERENT NEUROMODULATION DEVICE MANUFACTURER. THE NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS IMPLANTED ON (B)(6) 2023. AFTER THE IMPLANT THE PATIENT REPORTED FEELING TONIC SENSATION IN THE DESIRED LOCATION AND ALL SYSTEM TESTING RETURNED NORMAL RESULTS, HOWEVER THE PATIENT REPORTED DISSATISFACTION WITH THE LEVEL OF PAIN RELIEF BEING ATTAINED. MULTIPLE ATTEMPTS WERE MADE TO TROUBLESHOOT AND REPROGRAM IN ORDER TO ACHIEVE ADDITIONAL PAIN RELIEF FOR THE PATIENT. PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED DUE TO INABILITY TO ACHIEVE THE DESIRED EFFECTS FROM THE SYSTEM. FULL SYSTEM WAS EXPLANTED ON (B)(6) 2023. NALU WAS NOT MADE AWARE OF THE EXPLANT PROCEDURE UNTIL (B)(6) 2023, THUS NO REPRESENTATIVES WERE PRESENT AT THE PROCEDURE AND WERE UNABLE TO OBTAIN THE EXPLANTED DEVICE FOR TESTING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17608518 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH A PNS SYSTEM IN (B)(6) 2021. LEADS WERE PLACED ON THE SUPERIOR AND INFERIOR SUPRASCAPULAR NERVES. DURING THE CASE IT WAS NOTED THAT THE PATIENT HAD VERY THICK SKIN AND INCISIONS AND NEEDLE ENTRIES WERE DIFFICULT. IT WAS ALSO NOTED THAT THE PATIENT IS ON DIALYSIS. ON (B)(6) 2022 THE PATIENT REPORTED THAT THE LEADS HAD "FALLEN OUT' OF THE PATIENT'S SKIN. PATIENT'S LEADS APPEARED TO HAVE ERODED OUT OF THE SURGICAL POCKET AND WERE EXPOSED. PATIENT'S PRIMARY CARE NOTED ELEVATED WHITE COUNT AND SUGGESTED THAT THE PATIENT DOES NOT GET THE NALU SYSTEM REPLACED AT THAT POINT IN TIME. NALU SYSTEM WAS EXPLANTED ON (B)(6) 2022. DOCTOR SUGGESTED THAT THE PATIENT DID NOT HEAL CORRECTLY AFTER THE PROCEDURE DUE TO ONGOING DIALYSIS AND THAT LIKELY CAUSED THE INCISION TO OPEN AND THE POCKET TO BE EXPOSED.

  Patient problems: Pocket Erosion

  MAUDE report 14939881 ↗