BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 25203311 · Received May 18, 2026

    Report

    Report Number
    1723170-2026-00757
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    January 1, 2010
    Report Date
    May 18, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM ARTICLE: EL KHOU Y, VAN LANEN RHGJ, WAGNER GL, TOUSSEYN S, DE BRUYN G, HOEBERIGS CMC, ET AL. PSEUDOANEURYSMS AS A COMPLICATION OF STEREOELECTROENCEPHALOGRAPHY: CASE SERIES AND CLINICAL RECOMMENDATIONS. EPILEPSIA. 2026;67:1193¿1205. HTTPS://DOI.ORG/10.1002/EPI.70048 A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    EL KHOU, Y., VAN LANEN, R. H., WAGNER, G. L., TOUSSEYN, S., DE BRUYN, G., HOEBERIGS, C. M., WAGEMANS, B. A., VAN DER LEIJ, C., KLINKENBERG, S., NELISSEN, J., KUBBEN, P. L., SCHIJNS, O. E., DINGS, J. T., & RIJKERS, K. (2025). PSEUDOANEURYSMS AS A COMPLICATION OF STEREOELECTROENCEPHALOGRAPHY: CASE SERIES AND CLINICAL RECOMMENDATIONS. EPILEPSIA, 67(3), 1193¿1205. HTTPS://DOI.ORG/10.1002/EPI.70048 ABSTRACT OBJECTIVE: STEREOELECTROENCEPHALOGRAPHY (SEEG) IS COMMONLY EMPLOYED IN THE WORKUP FOR EPILEPSY SURGERY IN PATIENTS WITH FOCAL DRUG-RESISTANT EPILEPSY (DRE). INTRACRANIAL HEMORRHAGE IS A KNOWN COMPLICATION, WITH REPORTED INCIDENCE RATES RANGING FROM .9% TO 19.1%. RARELY, PSEUDOANEURYSMS HAVE BEEN REPORTED IN LITERATURE AS A POTENTIAL CAUSE. THIS RETROSPECTIVE COHORT STUDY AIMS TO DESCRIBE THE OCCURRENCE, CLINICAL CHARACTERISTICS, AND MANAGEMENT OF IATROGENIC PSEUDOANEURYSMS FOLLOWING SEEG AND THE CLINICAL OUTCOME OF THE DESCRIBED CASES. METHODS: A COHORT OF 395 PATIENTS (4067 DEPTH ELECTRODES) WITH DRE WHO UNDERWENT SEEG WAS RETROSPECTIVELY ANALYZED. THE IDENTIFIED PATIENTS WITH PSEUDOANEURYSMS WERE ANALYZED IN DETAIL, FOCUSING ON TIMING OF DETECTION AND LOCATION OF THE ANEURYSMS, CLINICAL CHARACTERISTICS, MANAGEMENT STRATEGIES, AND CLINICAL OUTCOME. RESULTS: A SYMPTOMATIC IATROGENIC PSEUDOANEURYSM WAS IDENTIFIED IN SIX OF 395 CASES (1.5%), WITH A PER-ELECTRODE RISK OF .15% (6/4067); ALL OCCURRED AT THE M2/M3 BRANCHES OF THE MIDDLE CEREBRAL ARTERY. ALL SIX CASES PRESENTED WITH INTRACEREBRAL OR SUBARACHNOID HEMORRHAGE. ANEURYSMS WERE DETECTED WITH COMBINED CEREBRAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND TREATED WITHOUT COMPLICATIONS BY SURGICAL CLIPPING OR ENDOVASCULAR EMBOLIZATION. THE DEPTH ELECTRODE IMPLANTATION AND PLANNED SEEG RECORDING HAD TO BE EITHER PREMATURELY DISCONTINUED OR CANCELED IN FOUR OF SIX CASES. NO PATIENTS DIED; FIVE EXPERIENCED NEUROLOGICAL SYMPTOMS AND REQUIRED PROLONGED HOSPITALIZATION, WITH FOUR NEEDING ADDITIONAL REHABILITATION. SIGNIFICANCE: PSEUDOANEURYSMS FOLLOWING SEEG REPRESENT A SERIOUS COMPLICATION WITH SIGNIFICANT CLINICAL CONSEQUENCES AND WARRANT EARLY DETECTION AND INTERVENTION. OCCURRENCE IS UNDERREPORTED IN LITERATURE. IT IS RECOMMENDED TO USE CTA AND DSA WHEN A PSEUDOANEURYSM IS SUSPECTED, PARTICULARLY IN CASES OF IN TRAPARENCHYMAL OR SUBARACHNOID HEMORRHAGE, AND ESPECIALLY WHEN DEPTH ELECTRODES ARE IN CLOSE PROXIMITY TO A BLOOD VESSEL. 1. PATIENT 1: "FUSION OF PREOPERATIVE PLANNING MRI WITH POSTOPERATIVE CT OF THE SEEG ELECTRODE POSITIONS REVEALED A 6-MM DEVIATION OF ONE DEPTH ELECTRODE. ON DAY 3 POST-SEEG, DUE TO REDUCED RESPONSIVENESS, A FOLLOW-UP CT SCAN OF THE BRAIN (FIGURE 1C) SHOWED SWELLING, PROMPTING TREATMENT WITH MANNITOL, IN ADDITION TO STANDARD EXAM ETHASONE. THIRTY-SEVEN DAYS POST-SEEG, HE WAS READMITTED WITH SUDDEN HEADACHE, VOMITING, DECREASED CONSCIOUSNESS, RIGHT-SIDED WEAKNESS, AND A DILATED LEFT PUPIL. CT SHOWED A LARGE LEFT FRONTOTEMPORAL HEMATOMA. ON DAY 47, A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN WAS PLACED DUE TO VENTRICULAR ENLARGEMENT, FOLLOWED BY IMPLANTATION OF A VENTRICULOPERITONEAL SHUNT ON DAY 65, WHICH LED TO CLINICAL IMPROVEMENT AND DISCHARGE ON DAY 77. TWO DAYS LATER, HE WAS URGENTLY READMITTED WITH SEVERE NEUROLOGICAL DETERIORATION FROM RECURRENT INTRACEREBRAL AND INTRAVENTRICULAR BLEEDING (FIGURE 1F). A REPEAT SURGERY TO EVACUATE THE HEMATOMA STABILIZED HIM. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE PERFORMED, REVEALING A PSEUDO ANEURYSM FROM A LEFT INSULAR M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY." 2. PATIENT 2: "POSTOPERATIVE CT AND MRI REVEALED A SMALL INTRACEREBRAL HEMATOMA NEAR A LEFT MEDIAL TEMPORAL DEPTH ELECTRODE. ON DAY 9 POST-SEEG, THE PATIENT BECAME UNRESPONSIVE AND EXHIBITED RIGHT ARM PARALYSIS. A CT SCAN SHOWED A LEFT FRONTOPARIETAL HEMATOMA WITH BREAKTHROUGH INTO THE VENTRICULAR SYSTEM AND SIGNS OF HYDROCEPHALUS (FIGURE 2D). THE INTRACEREBRAL HEMORRHAGE FROM THIS PSEUDOANEURYSM RESULTED IN DISCONTINUATION OF SEEG REGISTRATION AND SIGNIFICANT NEUROLOGICAL DEFICIT. HE SUFFERS FROM MIXED DYSPHASIA, AS WELL AS PARESIS (MRC 4) OF THE RIGHT ARM AND HAND, AND TO A SLIGHTLY LESSER EXTENT, THE RIGHT LEG, AND PERSISTENT SEIZURES (ILAE 5), WITH NO IMPROVEMENT OVER TIME DESPITE REHABILITATION. ANALYSIS OF THE ELECTRODE POSITION REVEALED A 6.2-MM DEVIATION OF ONE DEPTH ELECTRODE, WITH ITS FINAL POSITION MAKING CONTACT WITH THE RUPTURED BLOOD VESSEL." 3. PATIENT 3: "DURING ELECTRODE PLACEMENT, ARTERIAL BLEEDING OCCURRED AT A SCREW SITE, LIKELY DUE TO AN UNSECURED STYLET SCREW, ALLOWING THE STYLET TO ADVANCE TOO FAR AND POSSIBLY DAMAGE A BLOOD VESSEL. POSTSURGERY, THE PATIENT DEVELOPED HEADACHE AND MIXED DYSPHASIA. A CT SCAN REVEALED A SMALL LEFT FRONTAL INTRAPARENCHYMAL HEMATOMA. DURING THE PROCEDURE, A REBLEED OCCURRED, NECESSITATING PARENT VESSEL OCCLUSION USING COILS AND REQUIRING HEMATOMA EVACUATION COMBINED WITH ELECTRODE EXPLANTATION. SHE NOW SUFFERS FROM MIXED DYSPHASIA AND COGNITIVE IMPAIRMENTS, INCLUDING SLOWED PROCESSING AND REDUCED ATTENTION, WITH PARTIAL IMPROVEMENT OVER TIME AND PERSISTENT SEIZURES." 4. PATIENT 4: "STANDARD POSTOPERATIVE CT ON DAY 1 POST-SEEG REVEALED A SMALL LEFT FRONTOTEMPORAL SUBDURAL HEMATOMA, BUT NO EVIDENCE OF AN ELECTRODE-RELATED ICH OR SAH. LATER THAT SAME DAY, THE PATIENT SUFFERED SEVERE HEADACHE AND CONFUSION. A CT SCAN REVEALED A PARENCHYMAL HEMATOMA IN THE RIGHT TEMPORAL REGION, ALONG WITH INTRAVENTRICULAR AND SUBARACHNOID BLOOD. THIS BLEEDING FROM THE PSEUDOANEURYSM RESULTED IN SIGNIFICANT CLINICAL DEFICITS, INCLUDING IMPAIRED MEMORY, EXECUTIVE FUNCTION, VISUAL PROCESSING, AND MIXED DYSPHASIA, WHICH PARTIALLY RESOLVED OVER THE POSTOPERATIVE 3 MONTHS FOLLOWING REHABILITATION; SEIZURES PERSIST." 5. PATIENT 5: "THE PROCEDURE WAS UNEVENTFUL; HOWEVER, POSTOPERATIVE IMAGING ON DAY 0 REVEALED AN INTRAPARENCHYMAL HEMATOMA, RIGHT FRONTAL INFERIOR NEAR A CAUDAL DEPTH ELECTRODE. THE PATIENT WAS DISCHARGED BUT WAS READMITTED ON DAY 16 DUE TO NEW CLINICAL SYMPTOMS, INCLUDING LEFT-SIDED CENTRAL FACIAL NERVE PARESIS AND HEMIBODY WEAKNESS. A CT SCAN REVEALED A LARGE FRONTAL HEMATOMA. THIS CASE OF PSEUDOANEURYSM WITH RIGHT FRONTAL HEMATOMA FOLLOWING SEEG REGISTRATION LED TO LEFT-SIDED HEMIPARESIS (MRC 4), MILD DYSARTHRIA, AND ANOMIA, WHICH GRADUALLY IMPROVED WITH REHABILITATION. HE CONTINUES TO EXPERIENCE SEIZURES. 6. PATIENT 6: "AFTER SURGERY, SHE WAS FREE OF FOCAL SEIZURES WITH IMPAIRED AWARENESS. HOWEVER, SEIZURES WITH NAUSEA FOLLOWED BY LANGUAGE DISTURBANCES (BOTH SPEECH AND UNDERSTANDING) PERSISTED. THE SEEG PROCEDURE WAS UNEVENTFUL, ALTHOUGH THE PATIENT EXPERIENCED HEADACHES AFTERWARD. POSTOPERATIVE CT IMAGING ON DAY 0 REVEALED AN ICH IN THE LEFT PARIETAL RE GION WITH SOME SUBARACHNOID BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542149 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1