Synergy 9734048Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994532398), received between Sep 30, 2016 and May 23, 2025 — classified as 4 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO LOAD AN EXAM FROM THE PLANNING STATION TO THE NAVIGATION SYSTEM, THEY WERE EXPERIENCING AN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077689 ↗
• MalfunctionApr 1, 2025Display or Visual Feedback Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A PROBLEM EXPERIENCED DURING SERVICING. AFTER THE FIRST LAUNCH, THE CRANIAL APPLICATION DID NOT START. THE APPLICATION UPDATE TO VERSION 3.1.5 WAS SUCCESSFUL, AND ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) CONFIGURATION WAS OK. AFTER ABOUT AN HOUR OF WORK, THE MONITOR BEGAN TO RESTART BY ITSELF. AFTER SOME TIME, IT SEEMED AS IF IT WAS NOT RECEIVING AN INPUT SIGNAL FROM THE GRAPHICS CARD. WHEN LEAVING THE HOSPITAL, THERE WAS NO IMAGE ON THE MONITOR, AND THE COMPUTER DID NOT START AND RESTARTED BY ITSELF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744232 ↗
• MalfunctionFeb 7, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO IMPORT IMAGES FOR DEEP BRAIN STIMULATION (DBS) THE SYSTEM DISPLAYED AN ERROR CODE 721 "CANNOT NEGOTIATE WITH QR SERVER", AND WHEN HE TRIED TO EXPORT IMAGES THE EXPORT FAILED. WHILE TROUBLESHOOTING THE ISSUE SEEMED TO RESOLVE, AT LEAST FOR IMPORTING IMAGES. IT COULD NOT BE VERIFIED WHETHER THE EXPORTING WAS RESOLVED. THE PROBABLE CAUSE OF THE ERROR 721 COULD BE A RESULT OF PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) BEING DOWN, OR AN INCORRECT AE TITLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338265 ↗
• MalfunctionJul 3, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM RECEIVED AN ERROR MESSAGE, "THE SYSTEM IS RUNNING IN LOW-GRAPHICS MODE," ALONG WITH THE UBUNTU GRUB MENU APPEARING. THE MESSAGE APPEARED THREE TIMES AND HAD NOT APPEARED AGAIN SINCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668389 ↗
• MalfunctionJul 6, 2021Display or Visual Feedback Problem; Human-Device Interface Problem; Display or Visual Feedback Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREEN OF THE NAVIGATION SYSTEM WAS BLUE WITHIN ORTHOGONAL VIEWS. IT WAS NOTED THAT, WHILE IN THE PLANNING PORTION OF THE APPLICATION SOFTWARE, THE MONITOR PICTURE WAS A BLUE SCREEN INSTEAD OF EXAM INFORMATION WHICH WAS EXPECTED TO DISPLAY THE TRAJECTORY VIEWS, CORONAL, AXIAL OR SAGITTAL VIEWS. IT WAS REPORTED THAT THE APPLICATION MENU WAS VISIBLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122176 ↗
• MalfunctionJun 14, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLANNING STATION SYSTEM WAS NOT BOOTING UP. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995034 ↗
• MalfunctionJun 2, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATED THE REPORTED ISSUE COULD NOT BE REPLICATED WHEN THEY ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920992 ↗
• MalfunctionMay 24, 2021Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE COMPUTER WOULD NOT START THE CRANIAL SOFTWARE. THERE WAS A FAILURE IN SR MANAGER THAT WAS UNRECOVERABLE. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869958 ↗
• MalfunctionMar 30, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE APPLICATION SOFTWARE WOULD NOT BOOT ON THE PLANNING SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CORRECT EVENT DATE IS (B)(6) 2020, NOT (B)(6) 2020. THE EVENT DESCRIPTION HAS BEEN UPDATED TO REFLECT THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589281 ↗
• MalfunctionMar 5, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLANNING SYSTEM WOULD NOT BOOT. IT WAS REPORTED THAT THE SYSTEM BOOTED TO A "BOOT DISC ERROR" MESSAGE AND WOULD NOT PROGRESS PAST THE PROMPT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423026 ↗
• MalfunctionFeb 12, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS UNRESPONSIVE AND STACKED WHEN USING THE STEALTHVIZ APPLICATION SOFTWARE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM RESTARTED AND WAS UNRESPONSIVE DURING THE SESSIONS/ ADDITIONALLY,. IT WAS REPORTED THAT THE USER WAS UNABLE TO TURN ON "STATISTICS MODE" IN THE APPLICATION SOFTWARE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321627 ↗
• MalfunctionFeb 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED PRIOR TO A CRANIAL RESECTION. IT WAS REPORTED THAT THE DTI EXAMS COULD NOT BE TRANSFERRED OVER DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM). THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259398 ↗
• MalfunctionJan 20, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS NOT A PROBLEM WITH THE MONITOR, BUT WITH THE PLANNING COMPUTER. WITH THIS WE HAD TO REPLACE THE ENTIRE PLANNING (MONITOR INCLUDED), AS SUGGESTED BY THE MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202178 ↗
• MalfunctionJan 8, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM HAD NO RESPONSE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139093 ↗
• MalfunctionAug 20, 2020Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTED TO BE CAUSED BY AN ISSUE WITH THE SITES PACS NETWORK.

  Patient problems: No Patient Involvement

  MAUDE report 10431466 ↗
• MalfunctionAug 17, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SCREEN FROZE WHEN BUILDING A TUMOR MODEL IN THE STEALTH VIZ APPLICATION. THIS OCCURRED WHEN MOVING FROM THE SEGMENTATION TAB TO THE VIEW TAB. AFTER THE SCREEN FROZE, IT WAS NECESSARY TO DO A HARD SHUT DOWN. WHEN BOOTED BACK ALL THE WORK WAS LOST AND THE DOCTOR DECIDED TO MOVE ON WITHOUT USING THE PLANNING STATION RIGHT BEFORE THE PATIENT WAS INDUCED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10417834 ↗
• MalfunctionMay 27, 2020Computer Software Problem; Mechanical Problem; Computer Software Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. AFTER ENTERING THE LOGIN AND PASSWORD TO THE SYSTEM, THE MONITOR REMAINED STUCK AT THE BLUE SCREEN WITH MANUFACTURER LOGO (SPLASH SCREEN). THE ISSUE PERSISTED IF THE SITE LOGGED IN WITH THE ADMIN LOGIN AS WELL. THE ISSUE WAS SUSPECTED TO BE RELATED TO HARD DISK DAMAGE. THE LOT NUMBER OF THE REPLACED SSD COULD NOT BE OBTAINED. THE MOST LIKELY CAUSE WAS NOT DETERMINED. THE PROVIDED INFORMATION WAS CONFIRMED VIA BIOMEDICAL TECHNICIAN AT THE SITE.

  Patient problems: No Patient Involvement

  MAUDE report 10092807 ↗
• MalfunctionFeb 11, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE WAS ATTEMPTING TO LOAD AN EXAM, THEY WERE RECEIVING AN ERROR MESSAGE STATING THAT THE DATA WAS NOT VALID. NO PATIENT PRESENT AT THE TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9695186 ↗
• MalfunctionJan 21, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE COMPUTER DOES NOT FULLY BOOT UP. IT STOPS ON "LOADING KERNEL" THERE WAS NO PATIENT PRESENT. ON 2020-JAN-10 IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS THAT THERE WERE SOME CORRUPTED FILES IN OPERATION SYSTEM. THE COMPUTER OF THE SYSTEM WILL BE REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9612832 ↗
• MalfunctionOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS NOT LOADING CORRECTLY. THE PET SCAN WAS LOADING AS A SINGLE DOT, AND WHEN THE SITE REPRESENTATIVE TRIED TO LEVEL THE EXAM IT IMMEDIATELY TURNED GREEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9235387 ↗
• MalfunctionJun 14, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHEN ATTEMPTING TO EXPORT AN ARCHIVE, THE EXPORT FAILS. THIS OCCURRED BECAUSE AS CRANIAL PACKAGED THE ORIGINAL DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) TO BE INCLUDED IN THE EXPORT, THAT ORIGINAL DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) CONTAINED A PRIVATE PHILIPS SCANNER, WHICH NAVIGATION SYSTEM DOES NOT SUPPORT. THE USER WAS ABLE TO EXPORT THE DATASET FROM THE NAVIGATION SYSTEM VIA THE NETWORK BUT NO CD/DVD/USB. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8701866 ↗
• MalfunctionJun 3, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT FOR THE LAST THREE EXAMS THE MANUFACTURER REPRESENTATIVE (REP) HAS DONE DTI MAPPING FOR, THE DEC MAP HAS BEEN SHIFTED POSTERIOR BY 2CM AND THIS CONTINUES THROUGH THE WHOLE EXAM NOT JUST THE BASE OF THE BRAIN STEM. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8662809 ↗
• MalfunctionMay 17, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT PATIENT ¿PLANIFICATION¿ COULD BE TRANSFERRED ONLY RANDOMLY. ¿PATIENT IMAGES ARE ALWAYS TRANSFERRED ANYWAY.¿ THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8622147 ↗
• MalfunctionMay 6, 2019Computer Software Problem; Computer Software Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE WAS COMPLAINING ABOUT INACCURATE RESULTS AFTER AUTO MERGE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8582169 ↗
• MalfunctionMar 18, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE MONITOR PICTURE SHOWED A BLUE SCREEN INSTEAD OF THE EXAM INFORMATION WHICH IS NORMALLY SHOWED WITHIN THE TRAJECTORY VIEWS OR CORONAL, AXIAL, SAGITTAL VIEWS.

  Patient problems: No Patient Involvement

  MAUDE report 8431053 ↗