Magnet M-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855547005137), received between Jun 21, 2017 and Sep 15, 2017 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

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.

• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED TO THE SURGEON THAT SHE FELT LEAKING FROM HER WOUND STARTING APPROXIMATELY THE WEEK OF (B)(6) 2017, 10 WEEKS AFTER INVASIVE MONITORING WHICH WAS IMMEDIATELY FOLLOWED BY RNS SYSTEM IMPLANT AND CONCURRENT RESECTION. NO OTHER SYMPTOMS WERE REPORTED. TREATMENT INCLUDED SURGICAL INTERVENTION TO CLOSE THE WOUND AND LUMBAR DRAIN TO ADDRESS THE CSF LEAK. NO CULTURES WERE TAKEN; THE SURGEON DID NOT BELIEVE THERE WAS AN INFECTION BUT PLANNED TO TREAT THE PATIENT PROPHYLACTICALLY WITH ANTIBIOTICS.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6868523 ↗
• InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONSET OCCURRED (B)(6) 2017, 2 DAYS AFTER RNS SYSTEM IMPLANTATION WITH CONCURRENT CORTICAL RESECTION. THE NEUROSURGEON REPORTED THAT THE PATIENT WAS UNRESPONSIVE AND PRESENTED WITH ACUTE NEUROLOGICAL DECLINE. PATIENT WAS FOUND TO HAVE A SUBDURAL HEMATOMA LOCATED PARA THE AREA OF THE CORTICAL RESECTION AND UNDERWENT EMERGENT SURGICAL DECOMPRESSION. CAUSE WAS IDENTIFIED AS A LEAK FROM CORTICAL ARTERIAL VESICLE. PATIENT WAS NOTED TO HAVE AN ANOMALOUS CORTICAL ARCHITECTURE. NO RNS SYSTEM PRODUCT WAS EXPLANTED IN RESPONSE TO THE EVENT.

  Patient problems: Hematoma

  MAUDE report 6658962 ↗