RNS® Neurostimulator Kit RNS-300M-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00855547005120), received between Aug 24, 2015 and May 15, 2024 — classified as 103 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (3 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 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ON (B)(6), DURING REVIEW OF THE PATIENT ECOG DATA, HIGH IMPEDANCE WERE OBSERVED ON THE RIGHT LEAD (SN (B)(6)). THIS IS INDICATIVE OF A LEAD BREAK. ARTIFACT WAS DUPLICATED WHEN THE PHYSICIAN PALPATED AROUND THE HEAD. EVIDENCE OF HIGH IMPEDANCE WAS NOTED TO HAVE STARTED AROUND (B)(6) 2023. DETECTION WAS MODIFIED. THERE IS NO REPORT OF A FALL OR TRAUMA THAT COULD HAVE CONTRIBUTED TO A LEAD BREAK. NO ACTION WAS TAKEN AT THAT TIME. ON (B)(6) 2024 - AFTER PERFORMING AN INTERROGATION ON THE PATIENT, IMPEDANCES 2 AND 3 ON THE RIGHT LEAD (SN (B)(6)) WERE FLAT AND CONTACT 3 ON THE LEFT LEAD (193790) EXHIBITED SIMILAR BEHAVIOR. THIS SUPPORTS THE HYPOTHESIS OF A SUSPECTED LEAD FRACTURE ON BOTH LEADS, AS IMPEDANCES SHOULD BE NORMAL AND EVERY TIME THEY WERE MEASURED, THEY WERE ABNORMAL. ON (B)(6) 2024, THE PATIENT UNDERWENT LEAD EXPLANTS. BOTH THALAMIC LEADS (RIGHT AND LEFT) THAT ARE SUSPECTED TO BE FRACTURED WERE REMOVED ALONG WITH THE RNS NEUROSTIMULATOR. THE PATIENT IS SCHEDULED TO HAVE A REIMPLANT, OF THE RNS SYSTEM AFTER AN MRI IS PERFORMED TO ESTABLISH NEW THALAMIC LEAD TARGETS. THERE IS NO INDICATION OF A RNS NEUROSTIMULATOR FAILURE. REIMPLANT OF THE RNS SYSTEM IS SCHEDULED FOR (B)(6) 202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325662 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED DRAINAGE AROUND THE INCISION SITE. ON (B)(6) 2022, THE PATIENT UNDERWENT A WOUND WASH OUT, AND PLASTIC SURGERY FOR SCALP WOUND CLOSURE. THE PATIENT WAS PLACED ON PICC ANTIBIOTICS FOR AN UNSPECIFIED TIME, BECAUSE OF A POSITIVE BACTERIAL CULTURE (KLEBSIELLA). DIAGNOSED AS A DEHISCENCE WITH DRAINAGE AND AS A DEEP INCISIONAL INFECTION. NOTE: THE NEUROSTIMULATOR WAS CONCURRENTLY REPLACED FOR APPROACHING END OF LIFE.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 14239639 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS EXPLANTED DUE TO AN INFECTION THAT STARTED AND PERSISTED SINCE SEEG REMOVAL. NOTE THAT SEEG REMOVAL ((B)(6) 2019) OCCURRED PRIOR TO THE DATE OF INITIAL PLACEMENT OF THE RNS SYSTEM ((B)(6) 2019). A WOUND WASHOUT WAS PERFORMED AT THE INCISION SITE (DATE UNSPECIFIED). THE PATIENT WAS PLACED ON MULTIPLE ANTIBIOTICS PRIOR TO REFERRAL TO INFECTION CONTROL. A SECOND OPINION WAS OBTAINED AT ANOTHER COMPREHENSIVE EPILEPSY CENTER WHERE THE PATIENT WAS ADVISED TO HAVE THE DEVICE EXPLANTED. THE RNS SYSTEM (NEUROSTIMULATOR AND ALL LEADS) WERE EXPLANTED AT THE EXPLANTING CENTER ON (B)(6) 2021. DIAGNOSED AS A SUPERFICIAL INCISIONAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11532513 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVIEW OF ADVERSE EVENT DATA FOR AN INVESTIGATOR INITIATED RETROSPECTIVE DATA COLLECTION STUDY, A SERIOUS ADVERSE EVENT WAS IDENTIFIED THAT HAD NOT PREVIOUSLY BEEN REPORTED TO NEUROPACE. THE EVENT, REPORTED AS RELATED OR POSSIBLY RELATED TO RNS SYSTEM NEUROSTIMULATION, INVOLVED THE PATIENT DEVELOPING SUICIDAL IDEATION REQUIRING HOSPITALIZATION. THE PATIENT'S VNS THERAPY SYSTEM WAS TURNED OFF 5 MONTHS PRIOR TO INITIAL IMPLANT OF THE RNS SYSTEM. THE PATIENT UNDERWENT PLACEMENT OF THE RNS SYSTEM WITHOUT COMPLICATION. TWO DAYS AFTER RNS SYSTEM RESPONSIVE STIMULATION WAS ENABLED, HE DEVELOPED SUICIDAL IDEATION REQUIRING HOSPITALIZATION. THE TREATING CLINICIAN ENABLED THE PATIENT'S VNS THERAPY SYSTEM AND WITH BOTH THE RNS SYSTEM AND VNS THERAPY SYSTEMS ENABLED IT WAS REPORTED THAT THE PATIENT'S CONDITION IMPROVED.

  Patient problems: Emotional Changes; No Code Available

  MAUDE report 10468663 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REVIEW OF ADVERSE EVENT DATA FOR AN INVESTIGATOR INITIATED RETROSPECTIVE DATA COLLECTION STUDY, A SERIOUS ADVERSE EVENT WAS IDENTIFIED THAT HAD NOT PREVIOUSLY BEEN REPORTED TO NEUROPACE. THE EVENT, REPORTED AS RELATED TO THE RNS SYSTEM IMPLANT, INVOLVED THE PATIENT DEVELOPING A SUBDURAL HEMORRHAGE CAUSING HEADACHE AND PHOTOPHOBIA. THE EVENT SELF-RESOLVED WITHOUT SURGERY BUT REQUIRED A LONGER HOSPITALIZATION. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Headache; Hemorrhage, Subdural

  MAUDE report 10466617 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CULTURE RESULTS WERE PROVIDED BY THE PHYSICIAN.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 9267111 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH POTENTIAL SKIN EROSION OVER THE RNS NEUROSTIMULATOR INCISION SITE. THE PATIENT WAS SCHEDULED WITH PLASTIC SURGERY TO REVISE THE INCISION SITE BORDER IN ORDER TO PREVENT INFECTION AND ENABLE HEALING. THE IMPLANTED RNS NEUROSTIMULATOR WAS EXPLANTED, A NEW NEUROSTIMULATOR WAS IMPLANTED, AND THE SKIN AT THE INCISION WAS EXAMINED. THE PLASTIC SURGEON EXCISED THE COMPROMISED SKIN AND THE INCISION SITE WAS CLOSED WITHOUT COMPLICATION. NO OTHER INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: Skin Erosion; Wound Dehiscence

  MAUDE report 9050465 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING CLINICIAN REPORTED THE PATIENT WAS EXPERIENCING BEHAVIORAL CHANGES, SPECIFICALLY: VULGARITY IN CONVERSATIONS, IRRESPONSIBILITY, AND LACK OF EMPATHY. THE CHANGES IN BEHAVIOR CORRESPONDED WITH PROGRAMMING CHANGES IMPLEMENTED ON (B)(6) 2019 AND WERE OBSERVED LEADING UP TO THE (B)(6) CLINIC VISIT. PER THE TREATING CLINICIAN, REDUCTION OF THE PROGRAMMED CURRENT RESULTED IN A DECREASE IN THE BEHAVIORAL CHANGES. THE PHYSICIAN WILL CONTINUE TO TITRATE THE RNS NEUROSTIMULATOR SETTINGS. THE PATIENT IS NOTED TO HAVE BEHAVIORAL ISSUES WITH HIS SEIZURES, HOWEVER THE CHANGES NOTED WERE NOT CONSISTENT WITH THE PATIENT'S MEDICAL HISTORY. THE PATIENT'S RNS SYSTEM LEADS ARE PLACED IN THE FRONTAL LOBE.

  Patient problems: Emotional Changes

  MAUDE report 8798425 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISCOMFORT NEAR IMPLANT SITE SINCE THE INITIAL RNS SYSTEM PLACEMENT. THE ISSUE WAS ASSESSED BY THE NEUROSURGEON AND FOUND NOT TO BE A SERIOUS ISSUE AND WOULD BE ADDRESSED WHEN THE PATIENT WAS SCHEDULED FOR A SUBSEQUENT PROCEDURE. THE PATIENT DECIDED TO PURSUE SURGERY SOONER AND ON (B)(6) 2019, THE NEUROSURGEON FOUND A SMALL AMOUNT OF BONE CEMENT NEAR THE TOP OF THE DEVICE WHICH WAS CAUSING THE DISCOMFORT. BONE CEMENT IS USED BY THIS CENTER TO COVER BURR HOLES. THE BONE CEMENT WAS REMOVED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 8798424 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT RNS SYSTEM PLACEMENT ON (B)(6) 2019. ON (B)(6) 2019, THE TREATING CENTER PERFORMED A DEBRIDEMENT AND IRRIGATION OF THE INFECTED INCISION SITE. ON (B)(6) 2019, THE RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED. ADDITIONAL DETAILS WERE NOT PROVIDED BY THE TREATING CENTER.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 8712159 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT DUE TO EXPECTED LOW BATTERY. ON (B)(6) 2019, THE PATIENT UNDERWENT SURGICAL DEBRIDEMENT OF THE INCISION SITE TO TREAT AN INFECTION. FOLLOWING THE DEBRIDEMENT, THE PATIENT WAS NOTED TO HAVE DEVELOPED WOUND EROSION WHICH WAS SUBSEQUENTLY SUTURED CLOSED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT PRESENTED WITH CONTINUED EROSION, AND IT WAS NOTED THAT THE FERRULE SCREW WAS OBSERVED THROUGH THE SKIN EROSION. THE TREATING CENTER SCHEDULED THE PATIENT FOR SURGICAL INTERVENTION ON (B)(6) 2019. THIS PATIENT HAS A HISTORY OF SCALP INFECTIONS PRIOR TO IMPLANTATION OF THE RNS SYSTEM.

  Patient problems: Bacterial Infection; Erosion; Unspecified Infection

  MAUDE report 8695923 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT'S RNS NEUROSTIMULATOR AND ALL LEADS WERE EXPLANTED TO TREAT AN INFECTION. NO FURTHER DETAILS WERE PROVIDED BY THE TREATING CENTER.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 8354686 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT'S MOTHER NOTED SOME PURULENT DRAINAGE FROM THE SCALP SURGICAL SITE. A CULTURE WAS (B)(6) FOR (B)(6). THE PATIENT WAS TREATED WITH AN ORAL ANTIBIOTIC. THE PATIENT CONTINUED TO BE TREATED WITH THE RNS SYSTEM. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 8134537 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING CENTER INFORMED THE NEUROPACE FIELD CLINICAL ENGINEER THE PATIENT WAS UNDERGOING RNS SYSTEM EXPLANT (NEUROSTIMULATOR AND ALL LEADS) ON (B)(6) 2018 DUE TO INFECTION. THE TREATING CENTER REPORTED THIS AS A DEEP INCISIONAL INFECTION. THE PATIENT IS CURRENTLY BEING TREATED WITH IV VANCOMYCIN. NO OTHER DETAILS WERE PROVIDED BY THE TREATING CENTER.

  Patient problems: Unspecified Infection

  MAUDE report 8048124 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO MEMORIAL HERMANN NEUROSURGERY TODAY FOR EXPLANT OF THE ENTIRE RNS SYSTEM DUE TO HEMORRHAGE AT THE RNS LEAD SITE. THE PATIENT REPORTED HEADACHES BEFORE GOING TO THE HOSPITAL. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED BY THE TREATING CENTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7920912 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD EXPERIENCED AN INFECTION BUT LIMITED DETAILS HAD BEEN PROVIDED BY THE TREATING CENTER. ADDITIONAL DETAILS HAVE SINCE BEEN PROVIDED.

  Patient problems: Bacterial Infection; Purulent Discharge; Unspecified Infection

  MAUDE report 7853776 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED THE TREATING SITE REPORTING HE HAD LARGE AMOUNTS OF FLUID DRAINING FROM THE BACK OF HIS HEAD. SURGICAL IRRIGATION WAS PERFORMED ON (B)(6) 2018 AND VANCOMYCIN POWDER WAS ADMINISTERED. IN ADDITION, THE PATIENT RECEIVED TREATMENT WITH VANCOMYCIN AND CEFIPIME AND A PRESCRIPTION FOR BACTRIM WAS PROVIDED AT TIME OF DISCHARGE. THE RNS SYSTEM REMAINS IMPLANTED AND PROGRAMMED FOR TREATMENT. THE TREATING SITE CATEGORIZED THIS AS A SUPERFICIAL INCISIONAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7828228 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO THE TREATING CENTER'S EPILEPSY MONITORING UNIT ON (B)(6) 2018 IN POSSIBLE STATUS EPILEPTICUS. THE PATIENT REMAINS IN STATUS AS OF (B)(6) 2018. THE PATIENT UNDERWENT A COMBINED RESECTION AS WELL AS A RNS NEUROSTIMULATOR AND CORTICAL STRIP IMPLANTATION PROCEDURE ON (B)(6) 2018. THE ON-CALL EPILEPTOLOGIST STATED THAT SHE CANNOT RULE OUT THE POSSIBILITY THAT THIS IS RELATED TO THE PROCEDURE PERFORMED ON (B)(6) 2018 WHICH INCLUDED A RESECTION. STIMULATION WAS ENABLED ON (B)(6) 2018 IN AN EFFORT TO SEE IF THE PATIENT WOULD BENEFIT FROM THERAPY.

  Patient problems: Seizures

  MAUDE report 7828155 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN AND DISCOMFORT AT IMPLANT SITE. TO IMPROVE PATIENT COMFORT, THE DECISION WAS MADE TO RETURN TO THE OPERATING ROOM WHERE THE SKULL WAS SHAVED AROUND THE FERRULE TO ALLOW IT TO SIT MORE FLUSH WITH THE SKULL. A NEW FERRULE WAS THEN IMPLANTED AND THE EXISTING NEUROSTIMULATOR PLACED BACK IN THE FERRULE. THERE IS NO INDICATION OF PRODUCT MALFUNCTION OR FAILURE. THE RNS NEUROSTIMULATOR REMAINS IMPLANTED AND PROGRAMMED FOR DETECTION AND STIMULATION.

  Patient problems: Discomfort; Pain

  MAUDE report 7807849 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CRASHED HIS ATV ON (B)(6) 2018; AS A RESULT HIS INCISION OPENED EXPOSING THE RNS NEUROSTIMULATOR. ANTIBIOTICS WERE ADMINISTERED BY THE EMERGENCY ROOM AND THE PATIENT WAS REFERRED TO NEUROSURGERY. THE RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED ON (B)(6) 2018. NO INFECTION WAS SUSPECTED; HOWEVER CULTURES WERE TAKEN AND RESULTS ARE PENDING.

  Patient problems: Head Injury; Injury

  MAUDE report 7687449 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING CENTER REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WAS EXPOSED AT THE IMPLANT SITE. THE NEUROSTIMULATOR HAD BEEN IMPLANTED AT A LOCATION WHERE THREE PRIOR SURGERIES HAD OCCURRED, AND THE TREATING CENTER FELT THAT THE PATIENT'S SCALP HAD BEEN COMPROMISED DUE TO THE MULTIPLE SURGERIES. THE NEUROSTIMULATOR WAS EXPLANTED ON (B)(6) 2018, AND A PLASTIC SURGEON WAS UTILIZED DURING THE PROCEDURE TO ASSIST WITH THE COMPROMISED SCALP. THE LEADS REMAINED IMPLANTED. THE TREATING CENTER CATEGORIZED THE EVENT AS AN EROSION WITH POSSIBLE INFECTION (DEEP INCISIONAL).

  Patient problems: Skin Erosion; Wound Infection

  MAUDE report 7681606 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NEUROSURGEON REPORTED THAT THE PATIENT HAD A PIN-HOLE SIZED OPENING ALONG THE INCISION. THE PATIENT WAS TAKEN TO THE OR ON THE NIGHT OF (B)(6) 2018 FOR CLEANING OF THE INFECTED AREA. THE INFECTION WAS DETERMINED TO BE MORE SIGNIFICANT THAN ANTICIPATED AND THE PATIENT WAS SCHEDULED FOR EXPLANT OF THE RNS SYSTEM. THE NEUROSTIMULATOR AND ALL LEADS WERE EXPLANTED ON (B)(6) 2018. THE INFECTION WAS CATEGORIZED BY THE TREATING SITE AS DEEP INCISIONAL.

  Patient problems: Unspecified Infection

  MAUDE report 7645795 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT REPORTED DRAINAGE FROM THE INCISION SITE. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE OR WHERE THE INCISION WAS DEBRIDED AND CEFAZOLIN WAS PRESCRIBED FOR TREATMENT. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED TO THE OR AND THE RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED. THE TREATING CENTER CATEGORIZED THIS EVENT AS A SUPERFICIAL INCISIONAL INFECTION.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 7514470 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR RED, PAINFUL SCALP AND FEVER. HE WAS SEEN BY AN INFECTIOUS DISEASE SPECIALIST AND PRESCRIBED ANTIBIOTICS FOR SCALP CELLULITIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS SEEN BY HIS NEUROLOGIST AND ANOTHER WEEK OF ANTIBIOTICS WAS PRESCRIBED. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2018, AT WHICH TIME IT WAS DETERMINED THAT THE SYSTEM WOULD BE EXPLANTED ON (B)(6) 2018. NEUROPACE RECEIVED THE EXPLANTED RNS SYSTEM (NEUROSTIMULATOR AND LEADS). THERE WAS NO EVIDENCE OF FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO EVIDENCE OF PRODUCT MALFUNCTION OR FAILURE.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 7446764 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE PATIENT WAS SEEN FOR SEVERE RIGHT-SIDED HEADACHE, NAUSEA AND VOMITING, AND PHOTOSENSITIVITY, ALL ASSOCIATED WITH INCREASED FREQUENCY OF RIGHT TEMPORAL ONSET SEIZURES. CT SCAN REVEALED THAT THE PATIENT HAD AN INTRAPARENCHYMAL SUBDURAL HEMORRHAGE IN THE RIGHT TEMPORAL LOBE LOCATED NEAR THE RIGHT DEPTH LEAD. THE PATIENT WAS ADMITTED TO THE ICU FOR MONITORING, AEDS WERE ADJUSTED, AND SERIAL HEAD CTS WERE PERFORMED TO MONITOR BLEEDING STABILITY. STIMULATION OVER THE RIGHT HIPPOCAMPAL ELECTRODE WAS DISABLED. THE PATIENT HAD NO RESIDUAL NEUROLOGICAL SEQUELAE. THE PATIENT WAS DISCHARGED. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED BY THE TREATING CENTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7372119 ↗