NeuroPace® Remote Monitor Kit 5107Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855547005427), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Electrical /Electronic Property Problem; Fire

  INVESTIGATION RESULTS, REFER TO SECTION H10 ADDITIONAL INFORMATION: THE THERMAL EVENT RESULTED IN THE PATIENT SUSTAINING BURNS TO THEIR LEFT PALM, RIGHT FINGERTIPS, AND RIGHT ARM ABOVE THE ELBOW. WE NOTED A DISCREPANCY IN THE INFORMATION OBTAINED RELATING TO THE PATIENT. THE FDA REPORT SUBMITTED BY THE PHYSICIAN (MW5182362) REPORTED THE PATIENT SUSTAINED SUPERFICIAL (FIRST DEGREE) BURNS. NPCE WAS INFORMED BY THE MOTHER THAT THE PATIENT SUSTAINED THIRD-DEGREE BURNS TO LEFT PALM AND RIGHT FINGERTIPS AND A FIRST-DEGREE BURN TO RIGHT ARM ABOVE THE ELBOW. THE INITIAL MDR REPORTED BY NEUROPACE, INCLUDED THE INFORMATION AS REPORTED BY THE MOTHER (AS THIRD-DEGREE BURN TO LEFT PALM AND RIGHT FINGERTIPS AND FIRST-DEGREE BURN TO RIGHT ARM ABOVE THE ELBOW). ORIGINAL REPORT ON (B)(6) 2026, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S REMOTE MONITOR IGNITED AT APPROXIMATELY 9:40 PM ON (B)(6) 2025. ACCORDING TO HER ACCOUNT, THE PATIENT WAS INTERROGATING HIS NEUROSTIMULATOR WITH THE TRM (SN (B)(6)). DURING THAT TIME THE MOTHER REPORTED THE TRM INITIALLY DISPLAYED ITS NORMAL SCREEN, BUT THEN STARTED GLOWING ORANGE, ACTIVELY BURNING, AND PRODUCING SMOKE. THE MOTHER REPORTED THAT THE PATIENT HAD

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 24104387 ↗