N/A 9734070Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994719225), received between Feb 6, 2017 and Aug 22, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2018Failure to Fire; Failure to Fire

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SOFTWARE DISPLAYS AN ERROR RELATING TO TEMPERATURE, NOT ALLOWING THE SYSTEM TO PERFORM A SCAN. THERE WAS NO IMPACT TO PATIENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806598 ↗
• MalfunctionFeb 28, 2018Computer Software Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected; Computer Software Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE PERFORMING A PLANNED MAINTENANCE (PM), THE COMPUTER SHUT DOWN WITHOUT PROMPT FROM THE USER. IT WAS NOTED THAT A SECOND ISSUE WITH THE BIOS SETTINGS WAS FOUND BY THE MEDTRONIC REPRESENTATIVE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7304001 ↗
• MalfunctionFeb 26, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION, THE MAGNETIC RESONANCE IMAGING (MRI) IMAGE ACQUISITION DISCONTINUED WITHOUT PROMPT FROM THE USER. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7296614 ↗
• MalfunctionSep 15, 2017Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  A SITE REPRESENTATIVE REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE, THE SITE WAS UNABLE TO PERFORM ANY SCANS WITH THE IMAGING SYSTEM AND THE COIL SIGNAL IS ZERO ON BOTH SIDES. AFTER RESTARTING THE SYSTEM, AN ERROR IN RF-AMPLIFIER COMMUNICATION, ERROR MESSAGE WAS DISPLAYED. CALIBRATING THE SYSTEM DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF IMAGING. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO INFORMATION WAS PROVIDED ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868992 ↗
• MalfunctionMar 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT THE TOOL HAD BEEN BLOCKED BY THE SCANNER. THE SITE USED THE MANUAL OPEN PROCEDURE TO OPEN IT AND THEN ATTEMPTED TO RESTART THE SYSTEM, BUT IT WOULD NOT STARTUP. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6432046 ↗
• MalfunctionFeb 28, 2017Positioning Problem; Positioning Problem

  PER ATTACHED ARTICLE, FORWARDED BY A MEDTRONIC REPRESENTATIVE, THE USE OF THE IMAGING SYSTEM WAS REPORTED IN THE STUDY. IN JUNE 2012, THE FACILITY ACQUIRED AN INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IOMRI) SYSTEM. FROM JUNE 2012 TO APRIL 2014, 109 NEUROSURGICAL PROCEDURES USING IOMRI WERE PERFORMED. THE PROCEDURES INCLUDED GLIOMA (35.77%), PITUITARY ADENOMA (24.77%), AND MENINGIOMA RESECTION (16.51%), AS WELL AS A VARIETY OF INDICATIONS FROM BIOPSIES TO METASTASIS RESECTIONS AND BRAIN ABSCESS DRAINAGE. A TOTAL OF 159 PROCEDURES WERE INCLUDED,109 WERE CRANIAL SURGERIES ASSISTED BY ¿LOW-FIELD¿ IOMRI AND 50 WERE CONTROL CASES (NO IOMRI USED); BOTH GROUPS HAD SIMILAR TUMOUR AETIOLOGIES. TABLE 5 SHOWS THE MEAN TIMES BETWEEN PATIENTS WITH AND WITHOUT THE USE OF IOMRI. PATIENT POSITIONING WHEN USING IOMRI IS AFFECTED BY TECHNICAL REQUIREMENTS AND THE INDIVIDUAL ANTHROPOMETRIC CHARACTERISTICS OF EACH PATIENT. IN ADDITION, DEPENDING ON NECK LENGTH AND SHOULDER WIDTH, THE NEED FOR SHOULDER TRACTION IS DETERMINED, ESPECIALLY IN ADULT PATIENTS. SUCH TRACTION CAN CAUSE RESPIRATORY RESTRICTION, AND ALSO LEAD TO AXILLARY ARTERY OR BRACHIAL PLEXUS COMPRESSION. ALSO, A DOUBLE DOSE OF PARAMAGNETI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6365650 ↗
• MalfunctionFeb 15, 2017Electrical /Electronic Property Problem; Device Displays Incorrect Message; Device Operates Differently Than Expected; Electrical /Electronic Property Problem; Device Displays Incorrect Message; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED A MOTION ERROR MESSAGE: ¿RESET MOTION CONTROLLER AND RE-HOME THE MAGNET¿. THE ISSUE WAS RESOLVED BY PERFORMING THE RECOMMENDED ACTIONS THAT WERE DISPLAYED IN THE MESSAGES AND THE MESSAGES DID NOT POP-UP AGAIN. HOWEVER, THE MOTION SYSTEM FAILED AT THE END OF THE SURGERY AFTER IT WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6332433 ↗
• MalfunctionFeb 6, 2017Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, WHEN TRYING TO CONNECT THE NAVIGATION SYSTEM AND THEIR SURGICAL MRI SYSTEM, AN ERROR MESSAGE POPS UP SAYING THAT THERE WAS NO CONNECTION WITH THE SURGICAL MRI SYSTEM. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM, HOWEVER, WITHOUT THE SURGICAL MRI SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6305626 ↗