Visualase 9735542 (UDI 00643169655935)Recalls & reported problems

Summary

The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 00643169655935), received between Sep 29, 2016 and May 18, 2026 — classified as 2 deaths, 101 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (51 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 1, 2018Terminated

   Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

   Z-3251-2018 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 311 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S POST SCANS REVEALED A BLEED. THERE WAS NO DELAY TO THE PROCEDURE. THE PATIENT HAS HAD NO IMPACTS SINCE THE PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 25206288 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT A PATIENT MAY HAVE SUSTAINED NERVE DAMAGE AS A RESULT OF AN ABLATION CASE PERFORMED INVOLVING THIS SYSTEM. SPECIFICALLY AFTER THE PROCEDURE THE PATIENT NOW HAS A DEFICIT TO CRANIAL NERVES 7 AND 8, CAN'T MOVE HALF OF THEIR FACE AND HAS HEARING LOSS IN ONE EAR. PATIENT PRESENT, NO DELAY. EVERYTHING REPORTEDLY LOOKED GOOD AND NORMAL DURING ABLATION.

  Patient problems: Facial Paralysis; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Paralysis; Partial Hearing Loss; Unspecified Nervous System Problem

  MAUDE report 24887248 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRAIN HEMORRHAGE WHILE SETTING UP FOR A NEURO ABLATION CASE. NO ABLATION WAS PERFORMED; THE ISSUE OCCURRED AFTER PLACING TWO CATHETERS WITH A ROBOT AND WAS NOTICED AFTER INITIAL MAGNETIC RESONANCE IMAGING (MRI) SCANS. THE SURGEON OPTED TO ABORT THE PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24818196 ↗
• MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT TMAP WAS NOT TRANSFERRING. DURING THE CASE THE SYSTEM WOULD NOT TRANSFER TMAP IMAGES PROPERLY INTO THE SESSION. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO RE-LOAD THE IMAGES, THE MANUFACTURER REPRESENTATIVE (REP) REBOOTED THE SYSTEM AND THE ISSUE SEEMED TO RESOLVE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344702 ↗
• MalfunctionJan 2, 2026Erratic or Intermittent Display; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE THERMAL ABLATION SYSTEM DISCONNECTED FROM THE MRI DURING SURGERY ON (B)(6) 2025. A MANUFACTURER REPRESENTATIVE (REP) HAD DONE PRE SURGERY CHECKS AND FOUND THAT WHILE TESTING THERMAL MAPS (TMAPS) ON A PHANTOM KIT, THE SCANNER DISCONNECTED AFTER RUNNING FOR A FEW MINUTES. THE REP WAS ABLE TO REPLICATE THIS BUT WITH VARIOUS TIME BEFORE IT DISCONNECTED. REP CHECKED TMAP PARAMETERS, LOWERED SCANNER REPETITION TIME TO DECREASE SCAN TIME, AND CHECKED CONNECTIONS WITH NO SUCCESS. MRI SCANNER APPLICATION WAS REBOOTED, ACCESS-I ROUTER REBOOTED, ETHERNET CABLE SWAPPED, PULLED OVER ANOTHER 2 PLANE TMAP FROM A FOLDER OF PROTOCOLS FROM INSTALL, CHECKED PARAMETERS AND USED IT. REP WAS THEN ABLE TO RUN A 8-10+ MINUTE TMAP SESSIONS WITH NO ABRUPT DISCONNECTIONS. REP WAS ABLE TO USE THERMAL ABLATION SYSTEM FOR TWO CASES WITHOUT ISSUE. ON THE THIRD CASE, THEY HAD COMPLETED MULTIPLE ABLATIONS WITH PULLBACKS BEFORE THE SYSTEM DISCONNECTED FROM THE SCANNER ON THE LAST ABLATION BEFORE CASE COMPLETION. REP RAN A NEW SESSION, BUT SCANNER DISCONNECTED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943669 ↗
• MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE THERMAL DAMAGE WAS UNDERESTIMATED. THE THERMAL DAMAGE INFLICTED BY THE SYSTEM WAS UNDERESTIMATED DUE TO INACCURATE TE PARAMETERS. PARAMETERS HAVE SINCE BEEN CORRECTED. THERE WAS NO DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SYSTEM WAS OVERESTIMATED DAMAGE MODEL ESTIMATE, DUE TO INACCURATE TE PARAMETER, COMPARED TO VISUALIZED DAMAGE ON DWI SEQUENCE POST ABLATION. TE PARAMETER WAS CORRECTED FOR SUBSEQUENT ABLATIONS. DAMAGE MODEL AND POST IMAGING SCANS CORELATED THEREAFTER. ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM OVERESTIMATED DAMAGE MODEL ESTIMATE, DUE TO INACCURATE TE PARAMETERS, COMPARED TO VISUALIZED DAMAGE ON DWI SEQUENCE POST ABLATION. TE PARAMETER WAS CORRECTED FOR SUBSEQUENT ABLATIONS. DAMAGE MODEL AND POST IMAGING SCANS CORELATED THEREAFTER. THE SYSTEM SETTINGS WERE INCORRECT RELATED TO OUR ALGORITHM USED BY OUR SOFTWARE TO ESTIMATE THE DAMAGE TO BRAIN SOFT TISSUE. THIS MEANS THE SYSTEM'S ESTIMATED DAMAGE VISUALIZED ON THE SCREEN, DURING THE CASE IN QUESTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827047 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY, WHEN THE CATHETER WAS BEING REMOVED, IT RESULTED IN A PATIENT BRAIN BLEED. THE SURGEON HAD TO PLACES AN EXTERNAL VENTRICULAR DRAINAGE (EVD) FOR THE BLEED. AFTER A WEEK THE PATIENT WAS RELEASED HOME WITH NO PROBLEMS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23464279 ↗
• MalfunctionSep 11, 2025Energy Output Problem; Energy Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WERE TEMPERATURE MAP (TMAP) INACCURACIES. THE SURGEON DECIDED TO DO ANOTHER BURN IN A DIFFERENT LOCATION, AND THE TMAP TEMP MARKERS WERE JUMPING 10+/- DEGREES, THEY TRIPPED THE LOW MARKERS TWICE WITHOUT EVEN TURNING THE LASER ON. THE SITE TRIED RESETTING PHASE REFERENCE AND RESETTING TMAP. THEY ABORTED THAT ADDITIONAL ABLATION AS IT WAS NOT ABSOLUTELY NECESSARY. THE SCAN WAS NOISY, IT WAS ON THEIR 1.5T SYSTEM, PATIENT HAD VNS AND RNS AND HEADFRAME ON, CONTRIBUTING TO NOISE IN SCAN. THE PHYSICIST CHANGED SETTINGS EVEN THOUGH THE MANUFACTURING REPRESENTATIVE (REP) INFORMED NOT TO, SO KNOWN FLIP ANGLE WAS SWAPPED FROM 30 TO 15. OTHER SETTING WERE ALSO NOT TO PARAMETERS, WHICH POTENTIALLY CAUSED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026823 ↗
• MalfunctionSep 10, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE FLOW RATE GIVEN BY THE SALINE PUMP DURING THIS CASE WAS JUST SUFFICIENT FOR THE CASE WHEN TURNED UP TOWARD THE MAX. THERE WAS NO REPORTED DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS A VISUALASE LASER ABLATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016038 ↗
• MalfunctionJul 29, 2025No Device Output; No Device Output

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THEY WENT TO LOAD IMAGES AND WHEN THE WINDOW POPPED UP, THE WHOLE SCREEN WENT GRAY AND UNRESPONSIVE. THEY WERE UNABLE TO CLICK ON ANY BUTTONS. THEY PERFORMED A HARD SHUTDOWN AND WERE ABLE TO CONTINUE WITH THE SURGERY. THE MRI BACKGROUND IMAGES WERE REVIEWED BY THE MEDTRONIC REPRESENTATIVE (REP) IN THE VIRTUAL DATA TRANSFER (VDT) WINDOW AND HE SELECTED "EXPORT IMAGES" SO THEY WOULD BE LOADABLE IN THE SESSION. HE SELECTED NEW SESSION AND THEN "START SESSION." ALL THE SESSION WINDOWS POPULATED, ON BOTH TOP AND BOTTOM SCREEN, BUT NO INFORMATION, LABELS, BUTTONS ETC WERE THERE/VISIBLE/USABLE. ALSO, HE COULD NOT EXIT ANY WINDOWS. HITTING END SESSION DID NOTHING AS WELL. THE REP EVEN TRIED PRESSING CONTROL+ALT+DELETE ON THE KEYBOARD, BUT NOTHING HAPPENED. HE ENDED UP HAVING TO HOLD THE CPU POWER BUTTON UNTIL THE SYSTEM PERFORMED A HARD SHUTDOWN. THE REP WAITED 10 SECONDS AND PRESSED THE CPU POWER BUTTON TO TURN THE SYSTEM BACK ON. EVERYTHING WORKED AS USUAL AFTER THE RESTART. THIS WAS THE SECOND CASE OF THE DAY AND EVERYTHING WORKED AS IT SHOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648555 ↗
• MalfunctionJul 16, 2025Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device; Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A POSSIBLE INACCURATE THERMOGRAPHY ON THE SYSTEM. DURING A LASER ABLATION, THE SITE WAS ABLATING A TUMOR THAT HAD JUST HAD A BIOPSY TAKEN OF IT. THE ABLATION NEEDLE WAS FED DOWN THE BIOPSY NEEDLE. THE CALCULATION FROM THE THERMOGRAPHY SHOWED AN UNDESIRED ABLATION THAT CROSSED THE MIDLINE. THE SITE BELIEVED THE THERMOGRAPHY IMAGING THAT CROSSED THE MIDLINE TO BE DUE TO AN ARTIFACT. THE SITE WAS ABLATING USING THE BIOPSY CAVITY, WHICH HAS AIR AND BLOOD IN IT, WHICH WOULD AFFECT THE THERMOGRAPHY SCANS. THE SITE NOTICED THE BOWTIE EFFECT "BUBBLE ARTIFACT" AS A RESULT OF THIS THERMOGRAPHY ARTIFACT. THE SITE DID POST IMAGING AND FOUND THAT THEY HAD NOT ABLATED ACROSS THE MIDLINE, WHICH CONTRADICTED WHAT THE THERMOGRAPHY HAD SEEN. THERE WAS NO REPORTED DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517005 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A STROKE FOLLOWING A LASER ABLATION PROCEDURE. THERE WAS NO REPORTED DELAY TO THE CASE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS BEING TREATED FOR CANCER/BRAIN TUMOR AND WAS NEAR END OF LIFE BEFORE THE PROCEDURE. THE PATIENT WAS EXPECTED TO BEGIN HOSPICE THIS WEEK.

  Patient problems: Myocardial Infarction

  MAUDE report 22089299 ↗
• InjuryMar 31, 2025Energy Output Problem; Energy Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT AFTER A CASE, THE SURGEON REPORTED THAT THE PATIENT WAS APHASIC AND WEAK. THE SURGEON EXPRESSED CONCERNS ABOUT TOO MUCH EXPOSURE TO THE LASER. THE PATIENT WAS IMPACTED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE.

  Patient problems: Dysphasia; Muscle Weakness/Atrophy

  MAUDE report 21732479 ↗
• InjuryMar 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708214 ↗
• MalfunctionMar 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NON-MEDTRONIC SCANNER HAD SOFTWARE RECENTLY UPDATED AND A ROUTER INSTALLED. COMMUNICATION BETWEEN THE SCANNERAND THE THERMAL THERAPY SYSTEM WAS ESTABLISHED. HOWEVER, WHEN RUNNING THE 2-PLANE TEMPERATURE (TMAP), ONLY THE FIRST TWO SLICES WERE COMING INTO THE LIVE SESSION AND THEN THE CONNECTION WOULD TIME OUT. BOTH PLANES WERE VISIBLE IN THE REMOTE FOLDER AND THE "LAST IMAGE RECEIVED" INFO ON THE CONNECTION STATUS BAR WAS UPDATING CORRECTLY FOR A 2-PLANE TMAP. TROUBLESHOOTING WAS PERFORMED AND THE SCANNER WAS REBOOTED. IT WAS NOTED THAT THE SCANNER DID NOT SHUT DOWN CLEANLY, SO THE CUSTOMER HAD TO DO A HARD RESET. A MANUFACTURER REPRESENTATIVE REDID THE SCAN STEPS AND THE SAME PROBLEM WITH THE 2-PLANE TMAP OCCURRED. A 1-PLANE TMAP WORKED. A 3-PLANE TMAP WAS PERFORMED AND THAT ALSO DID NOT WORK. THE MANUFACTURER REPRESENTATIVE CHECKED THE SETTINGS ON THE 2-PLANE TMAP AND EVERYTHING LOOKED CORRECT. THE NON-MEDTRONIC SCANNER PROTOCOL WAS UPDATED WITH THE SOFTWARE TAGS AND THE 2D DISTORTION CORRECTION. THE UNFILTERED IMAGES WAS CHECKED AS REQUIRED FOR THE SOFTWAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653313 ↗
• MalfunctionMar 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE IMAGING PROTOCOL WAS CORRECTLY FOLLOWED TO RESOLVE THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643634 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION ROBOT BEING USED WITH THE NON-MEDTRONIC SYSTEM WAS OFF TWO TIMES WHILE USING THE LASER ABLATION SYSTEM. THE TRAJECTORY AND THE THIRD WAS ADJUSTED FOR THE OFFSET. THE SITE RAN A SPIN WITH THE IMAGING SYSTEM AND FOUND A BRAIN BLEED IN THE PATH OF THE LASER ABLATION SYSTEM LIKELY DUE TO THE MISSED TRAJECTORY OF THE ROBOT. THE PROCEDURE WAS THEN ABORTED AFTER THE BRAIN BLEED WAS DISCOVERED. ADDITIONAL INFORMATION WAS RECEIVED. THE SITE DID AN IMAGING SYSTEM SPIN TO CHECK THEIR PLACEMENT THE THIRD TRAJECTORY WAS IN GOOD PLACEMENT. THEY FOUND THE BLEED WHEN THEY ARRIVED ON MAGNETIC RESONANCE IMAGING (MRI) AND DID THE THREE-DIMENSIONAL FIRST THORACIC (3D T1) AND "IT WAS OBVIOUS." THE SITE DID A SECOND SCAN AND IT WAS DETERMINED THAT THE BLEED WAS GROWING. AT THIS POINT, THE SITE TRANSPORTED THE PATIENT BACK TO THE OPERATING ROOM (OR) FOR AN OPEN CRANIOTOMY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE WAS "NEVER CONCERNED IT WAS A [LASER ABLATION SYSTEM] PROBLEM." IT WAS "DEFINITELY" A ROBOT ISSUE. THE SITE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21610168 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT DURING A CASE, A BRAIN HEMORRHAGE WAS NOTICED AFTER THE BIOPSY, BUT BEFORE THE LASER ABLATION. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO OTHER IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21066842 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SANVITO, F., TELESCA, D., CHO, N.S., SAYARI, J.T., NAGARAJ, R., RAYMOND, C., RANA, S., PATEL, K., MOZAFFARI, K., UNTERBERGER, A.A., KHANLOU, N., MAGAKI, S., POURATIAN, N., EVERSON, R.G., YANG, I., KIM, W., ELLINGSON, B.M. SMALL PRETREATMENT LESION SIZE AND HIGH SPHERICITY AS FAVORABLE PROGNOSTIC FACTORS AFTER LASER INTERSTITIAL THERMAL THERAPY IN BRAIN METASTASES. J NEUROSURG. 2024. 140:338¿349. DOI: 10.3171/2023.5.JNS23285. OBJECTIVE THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY BASELINE CLINICAL AND RADIOLOGICAL CHARACTERISTICS OF BRAIN METASTASES (BMS) ASSOCIATED WITH A HIGHER PROBABILITY OF LESION-SPECIFIC PROGRESSION-FREE SURVIVAL (PFS-L) AFTER LASER INTERSTITIAL THERMAL THERAPY (LITT). METHODS A TOTAL OF 47 LESIONS IN 42 PATIENTS WITH BMS TREATED WITH LITT WERE RETROSPECTIVELY EXAMINED, INCLUDING NEWLY DIAGNOSED BM, SUSPECTED RECURRENT BM, AND SUSPECTED RADIATION NECROSIS. THE ASSOCIATION OF BASELINE CLINICAL AND RADIOLOGICAL FEATURES WITH PFS-L WAS ASSESSED USING SURVIVAL ANALYSES. RADIOLOGICAL FEATURES INCLUDED LESION SIZE MEASUREMENTS, DIFFUSION AND PERFUSION METRICS, AND SPHERICITY, WHICH IS A RADIOMIC FEATURE RANGING FROM 1 (PERFECT SPHERE) TO 0. RESULTS THE PROBABILITY OF

  Patient problems: Post Operative Wound Infection

  MAUDE report 20126269 ↗
• MalfunctionAug 28, 2024Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LASER GENERATOR WAS NOT TO SPECIFICATIONS. IT WAS WEAKER THAN WAS REQUIRED. THIS WAS NOTICED DURING PLANNED MAINTENANCE (PM). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088946 ↗
• MalfunctionAug 28, 2024Erratic or Intermittent Display; Electrical /Electronic Property Problem; Erratic or Intermittent Display; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM DISPLAYED ERROR 162 ("162 - SYSTEM OPTIONS NOT SET. YOUR SYSTEM CONFIGURATION HAS CHANGED SINCE YOUR LAST BOOT. ADDITION OF A HARD DRIVE, ETC., OR LOSS OF POWER TO THE REAL TIME CLOCK HAS OCCURRED. PRESSING F1 WILL RECORD THE NEW CONFIGURATION. IF THIS MESSAGE PERSISTS, YOU MAY NEED TO REPLACE THE ONBOARD BATTERY."). TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (REP) WAS ABLE TO PROCEED BY PRESSING F1 AND RESETTING THE DATE AND TIME. THE SYSTEM WAS OPERABLE. IT WAS NOTED THAT THE SUSPECTED CAUSE OF THE ISSUE WAS A MALFUNCTIONING COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087744 ↗
• MalfunctionAug 23, 2024Image Display Error/Artifact; Image Display Error/Artifact

  ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE HAS SINCE BEEN RESOLVED INTERNALLY. PROCEDURES HAVE SINCE BEEN COMPLETED WITH THE THERMAL THERAPY SYSTEM; THE IMAGING ISSUES HAVE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047262 ↗
• MalfunctionJul 24, 2024Image Display Error/Artifact; Image Display Error/Artifact

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE HAD SINCE DETERMINED THAT MANY OF THEIR RELATIVE TMAP IMAGING ARTIFACT ISSUES WERE DUE TO THE ANESTHESIA MACHINE BEING TOO CLOSE TO THE GAUSS LINE. SUBSEQUENT CASES HAVE BEEN BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821820 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT AFTER A SUCCESSFUL CASE, THE SURGEON CALLED MEDTRONIC TO REPORT THAT THE PATIENT HAD A BLOWN PUPIL AND WAS SYMPTOMATIC POST SURGERY. THE SURGERY WAS DONE CLOSE TO THE NERVE THAT CONTROLS VISION. POTENTIAL POSSIBLE DAMAGE TO THIRD NERVE DURING ABLATION.

  Patient problems: Visual Impairment

  MAUDE report 19548031 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INTRACRANIAL HEMORRHAGE. IT WAS NOTED THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE NEARBY THE STEREOTACTIC PLACED COOLING CATHETER SUPERIOR/ANTERIOR TO THE TRAJECTORY. THIS BLEED WAS FOUND DURING IMAGING SETUP FOR THE ABLATION. THE COOLING CATHETER HAD BEEN PLANNED AND INSERTED USING A STEREOTACTIC DEVICE (NON-MEDTRONIC). THE IMAGING SYSTEM WAS USED FOR PLACEMENT CONFIRMATION IMAGING INTRA-OPERATIVELY. THE HEALTH CARE PROFESSIONAL (HCP) OPTED TO PROCEED WITH ABLATION AND RUN MORE IMAGING TO EVALUATE THE NEXT STEPS. THE PROCEDURE CONCLUDED SUCCESSFULLY AND POST ABLATION THEY OPTED TO DO A WAKE UP TEST TO EVALUATE PATIENT NEXT STEPS. FOLLOW UP WITH THE HCP TO BE CONTINUED. THE PRODUCT AND PROCEDURE WAS NOT SPECIFICALLY NAMED AS A REASON FOR THE UNEXPLAINED HEMORRHAGE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE.

  Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142521 ↗