RNS® Neurostimulator Kit RNS-320-K (UDI 00855547005366)Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 00855547005366), received between Aug 14, 2020 and Jul 8, 2026 — classified as 2 deaths, 196 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) 26, THE PATIENT CALLED NEUROPACE REQUESTING INFORMATION REGARDING A MRI. AT THAT TIME THE PATIENT REPORTED SHE HAD A DEHISCENCE AT THE NEUROSTIMULATOR INCISION SITE AND WANTED TO HAVE AN MRI. NEUROPACE HAS BEEN UNABLE TO OBTAIN DETAILS RELATING TO THE REPORTED DEHISCENCE. THE PATIENT'S NEUROSTIMULATOR IS CURRENTLY IN MRI ENABLED MODE.

  Patient problems: Wound Dehiscence

  MAUDE report 25748919 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT PRESENTED TO THE (B)(6) EMERGENCY ROOM STATING HE HAD FALLEN. HIS IMPLANT INCISION SITE WAS INFECTED. THE PATIENT WAS ADMITTED FOR EXPLORATION SURGERY. UPON OPENING THE INCISION, THE INFECTION WAS FOUND AROUND THE UNCONNECTED LEADS AND NEUROSTIMULATOR. THE NEUROSTIMULATOR WAS REMOVED AND INFECTED LEADS WERE CUT DOWN AND REMOVED AT THE SKULL. TREATMENT INCLUDED UNSPECIFIED ORAL ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 25550928 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE INCISION SITE WAS REPORTED TO BE RED WITH A PURULENT DISCHARGE AND TENDER TO THE TOUCH. THE TREATING CENTER DIAGNOSED AN INFECTION. THE PATIENT WAS INITIALLY PRESCRIBED ORAL ANTIBIOTICS. ON (B)(6) 2026, THE PATIENT WAS REPORTED TO HAVE A WOUND WASHOUT AND PRESCRIBED IV ANTIBIOTICS. ON (B)(6) 2026 THE PATIENT HAD THEIR RNS SYSTEM FULLY EXPLANTED DUE TO INFECTION.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 25520601 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2026. THE PATIENT WAS REPORTED TO HAVE HAD A HEMORRHAGE FOLLOWING THE IMPLANT. DETAILS WERE NOT PROVIDED. TREATMENT DETAILS WERE NOT PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 25306787 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT REPORTED A SCAB NEAR THEIR INCISION SITE. THE INCISION HAD OPENED AND EXPOSED PART OF A LEAD. ON (B)(6) 2026, THE PATIENT HAD THEIR RNS SYSTEM (THE NEUROSTIMULATOR AND FOUR LEADS) EXPLANTED ALONG WITH A WOUND WASHOUT.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 25306499 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT REPORTED SWELLING OVER THE NEUROSTIMULATOR SITE. FLUID REMOVED FROM THE SWELLING WAS INDICATIVE OF INFECTION. ON (B)(6) 2026, THE NEUROSTIMULATOR WAS EXPLANTED. THE DEEP INCISIONAL INFECTION WAS TREATED WITH BROAD SPECTRUM IV ANTIBIOTICS FOR SIX WEEKS.

  Patient problems: Bacterial Infection; Swelling/ Edema

  MAUDE report 25219319 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT PRESENTED WITH RIGHT-SIDED WEAKNESS ONE DAY FOLLOWING DEVICE IMPLANTATION. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED AT THAT TIME DEMONSTRATED LEFT-SIDED EDEMA. AT 10 DAYS POST-IMPLANT, MAGNETIC RESONANCE IMAGING (MRI) REVEALED SEVERE LEFT-SIDED EDEMA. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF 10 DAYS. TREATMENT INCLUDED CORTICOSTEROIDS. CLINICAL IMPROVEMENT IN SYMPTOMS WAS REPORTED AFTER APPROXIMATELY FIVE DAYS OF STEROID THERAPY. FOLLOWING HOSPITALIZATION, THE PATIENT WAS DISCHARGED AND REFERRED FOR REHABILITATION. ON (B)(6) 2026, THE REPORTING PHYSICIAN INDICATED THAT THE PATIENT'S CONDITION HAD COMPLETELY RESOLVED.

  Patient problems: Muscle Weakness/Atrophy; Swelling/ Edema

  MAUDE report 25194544 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT WAS SEEN IN CLINIC WITH FEVER AND WOUND DEHISCENCE. HE WAS PRESCRIBED A 14 DAY COURSE OF IV KEFLEX. AT FOLLOW UP IN (B)(6) 2026, IMPROVEMENT OF THE INCISION SITE WAS NOTED. IN (B)(6) 2026, THE PATIENT RETURNED WITH RECURRENT WOUND DEHISCENCE AND PURULENT DRAINAGE. ON (B)(6) 2026, HE UNDERWENT EXPLANTATION OF THE RNS SYSTEM (NEUROSTIMULATOR AND TWO LEADS) WITH IRRIGATION AND DEBRIDEMENT OF THE INFECTED AREA. INITIAL CULTURES GREW STAPHYLOCOCCUS EPIDERMIDIS, AND HE WAS TREATED WITH IV VANCOMYCIN AND CEFEPIME THROUGH (B)(6) 2026. ON (B)(6) 2026, DUE TO PERSISTENT WOUND HEALING DIFFICULTIES, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REPEAT IRRIGATION AND DEBRIDEMENT. CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS CAPITIS. HE WAS TREATED WITH FOUR WEEKS OF IV VANCOMYCIN AND TWO WEEKS OF LINEZOLID. ON EVALUATION ON 5/4/26, THE WOUND WAS NOTED TO BE HEALED.

  Patient problems: Bacterial Infection; Purulent Discharge; Twiddlers Syndrome; Wound Dehiscence

  MAUDE report 25178187 ↗
• MalfunctionMay 11, 2026Premature Discharge of Battery

  H10 INVESTIGATION RESULTS: ORIGINAL REPORT: THE NEUROSTIMULATOR BATTERY REACHED END OF SERVICE AFTER 2.156 YEARS. THE BATTERY WAS REPLACED ON 4/17/26. REVIEW OF THE BATTERY PLOT INDICATED AN UNUSUAL BATTERY DEPLETION PATTERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142615 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE NEUROSTIMULATOR AND TWO OF FOUR LEADS WERE EXPLANTED DUE TO INFECTION. TWO DAYS LATER, THE REMAINING HARDWARE WAS REMOVED. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: Bacterial Infection

  MAUDE report 25142614 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PHYSICIAN NOTIFIED NPCE THAT THE PATIENT HAD PURULENT DRAINAGE FROM THE INCISION SITE. EXPLANT OF THE RNS SYSTEM WAS SCHEDULED. ON (B)(6) 2026, THE NEUROLOGIST REPORTED THAT NO CULTURES WERE AVAILABLE AND THAT MRSA WAS SUSPECTED. IT WAS NOTED THAT SHORTLY AFTER IMPLANTATION, THE PATIENT WAS INVOLVED IN A KNIFE FIGHT, ARRESTED, AND INCARCERATED, DURING WHICH TIME HE BEGAN TO SHOW SIGNS OF INFECTION. MEDICAL CARE WAS DELAYED AS A RESULT OF HIS ARREST, AND BY THE TIME HE WAS EVALUATED BY A SURGEON, THE INFECTION HAD PROGRESSED, NECESSITATING DEVICE REMOVAL. THE EXACT EXPLANT DATE IS NOT KNOWN AT THIS TIME.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 25115805 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING CENTER REPORTED A PROTRUSION AT INCISION SITE ON (B)(6) 2025. ACCORDING TO THE REPORT, THE PATIENT PICKED AT LEFT RNS INCISION SITE. THE PATIENT ALSO REPORTED HE HAD HIT HIS HEAD. UPON INSPECTION, THE PHYSICIAN OBSERVED A LOOP OF THE LEAD PROTRUDING FROM A 1CM X 1CM OPENING. ON (B)(6) 2025, THE PATIENT UNDERWENT WOUND REVISION AND WASHOUT, AS WELL AS REMOVAL OF THE DAMAGED LEAD. (THIS WAS NOT REPORTED TO NPCE) ALL CULTURES WERE REPORTED AS NEGATIVE AT THAT TIME. ON (B)(6) 2025 - THE PATIENT HAD WAS EXPLANTED (TWO NEUROSTIMULATORS AND TWO LEADS). TREATMENT INCLUDED ORAL KEFLEX FOR ONE WEEK. THE TREATING CENTER REPORTED THIS WAS DIAGNOSED AS A WOUND DEHISCENCE AND PROTRUSION. CULTURES WERE POSITIVE FOR CORYNEBACTERIUM.

  Patient problems: Bacterial Infection; Twiddlers Syndrome; Wound Dehiscence

  MAUDE report 25107564 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT WAS REPORTED TO HAVE AN INFECTION AT THE INCISION SITE. ON (B)(6) 2026, THE PATIENT HAD THE RNS SYSTEM EXPLANTED (NEUROSTIMULATOR AND TWO LEADS). TREATMENT INCLUDED ANTIBIOTICS (CEFTRIAXONE 2G IV EVERY 12 HOURS FOR A PLANNED 4-WEEK COURSE).

  Patient problems: Bacterial Infection

  MAUDE report 25107563 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT HAD A SECOND WASHOUT FOR SUPERFICIAL INFECTION ON THE OTHER SIDE OF THE INCISION, QUITE A DISTANCE AWAY FROM WHERE THE FIRST INFECTION WAS. THE SURGEON OPTED FOR A WOUND WASHOUT AND NO HARDWARE REMOVAL. THE PATIENT WAS ADMITTED THE DAY PRIOR TO SURGERY. THIS WAS REPORTED AS A RECURRENT STAPHYLOCOCCUS INFECTION. VANCOMYCIN WAS USED FOR THIS WASHOUT. ON (B)(6) 2026, THE PATIENT HAD THE NEUROSTIMULATOR EXPLANTED. ADDITIONAL DETAILS WERE NOT PROVIDED.

  Patient problems: Bacterial Infection

  MAUDE report 25075708 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  CLINICAL SUMMARY: THE ONSET OF THE EVENT WAS REPORTED AS FEBRUARY 18, 2026. CLINICAL COURSE AND PRESENTATION. A MONTH BEFORE PRESENTATION IN THE ER ON (DATE), THE PATIENT HAD BEEN EVALUATED IN CLINIC FOR A SMALL LESION AT THE VERTEX WITH MINIMAL INCISION SITE OOZING. AT THAT TIME, SHE WAS TREATED WITH A 14-DAY COURSE OF ORAL ANTIBIOTICS (CEPHALEXIN), WHICH RESULTED IN TEMPORARY IMPROVEMENT. FOLLOWING COMPLETION OF ANTIBIOTICS, THE PATIENT EXPERIENCED RECURRENT OOZING WITH INCREASED DRAINAGE FROM THE SITE. GIVEN THE PROGRESSION OF SYMPTOMS, SHE WAS ADMITTED ON (B)(6) 2026, AND UNDERWENT A LEFT OCCIPITAL CRANIOTOMY WITH WOUND EXPLORATION AND REMOVAL OF THE RNS NEUROSTIMULATOR AND ALL THREE DEPTH LEADS. SHE WAS TREATED WITH IV VANCOMYCIN, CEFTRIAXONE, AND CEFAZOLIN. INFECTION ASSESSMENT: THERE WAS NO EVIDENCE OF SYSTEMIC INFECTION. THE CLINICAL FINDINGS WERE CONSISTENT WITH A GENERATOR POCKET INFECTION WITHOUT INTRACRANIAL INVOLVEMENT, CLASSIFIED AS A DEEP INCISIONAL INFECTION.

  Patient problems: Drug Resistant Bacterial Infection; Fluid Discharge

  MAUDE report 25045967 ↗
• MalfunctionApr 22, 2026Failure to Interrogate; Failure to Transmit Record; Communication or Transmission Problem

  ON (B)(6) 2026, THE PATIENT'S DEVICE WAS PLACED IN MRI MODE IN PREPARATION FOR AN MRI. THE CLINIC STAFF ATTEMPTED TO DISABLE MRI MODE AFTER THE MRI WAS COMPLETED BUT WERE UNABLE TO COMMUNICATE WITH THE RNS NEUROSTIMULATOR. ANOTHER ATTEMPT WAS MADE BY THE RESIDENT ON (B)(6) 2026, BUT HE WAS ALSO UNABLE TO COMMUNICATE WITH THE DEVICE. ON (B)(6) 2026, THE PATIENT HAD THE RNS NEUROSTIMULATOR REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957595 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT REPORTED A REOPENING OF THE WOUND FROM A PRIOR WOUND WASHOUT. A WOUND WASHOUT AND EXPLANT OF A DEPTH LEAD AND RNS NEUROSTIMULATOR WERE PERFORMED. THE DEEP INCISIONAL INFECTION WAS TREATED WITH ORAL AND IV ANTIBIOTICS (ROCEPHIN/VANCOMYCIN).

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 24947694 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PROTRUSION OF HARDWARE FROM THE INCISION AREA. THE TREATING PHYSICIAN REPORTED NO SIGNS OF INFECTION, BUT THE FERRULE CLAMP HEADER WAS EXPOSED. ON (B)(6) 2026, THE PATIENT HAD THEIR RNS NEUROSTIMULATOR EXPLANTED AND REPLACED.

  Patient problems: Perforation; Rupture

  MAUDE report 24947693 ↗
• MalfunctionMar 30, 2026High impedance

  THE PATIENT'S ECOG DATA INDICATED THE LEFT MESIAL TEMPORAL DEPTH LEAD HAD HIGH IMPEDANCE, INDICATIVE OF A LEAD BREAK. DURING THE SCHEDULED LEAD REPLACEMENT SURGERY, THE SURGEON ELECTED TO REPLACE THE RNS NEUROSTIMULATOR. THE RNS NEUROSTIMULATOR WAS REPLACED AND THE LEFT MESIAL TEMPORAL DEPTH LEAD WAS CONNECTED TO THE NEW RNS NEUROSTIMULATOR. LIVE ECOG INDICATED THAT THE LEAD WAS FUNCTIONING AS EXPECTED WITH NO HIGH IMPEDANCE. THE SURGEON ELECTED TO LEAVE THE LEAD IN PLACE AFTER THE RNS WAS REPLACED. THE CAUSE APPEARS TO BE RELATED TO A FALL EXPERIENCED IN (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737488 ↗
• MalfunctionMar 30, 2026Failure to Interrogate; Communication or Transmission Problem

  ON (B)(6) 2025, THE PATIENT REPORTED BEING UNABLE TO INTERROGATE. BASED ON DEVICE SESSION REVIEW PERFORMED BY NEUROPACE, INTERROGATION WAS WORKING NORMALLY UNTIL 10/15/25. ON (B)(6) 2025, DURING A CLINIC VISIT THE DOCTOR WAS UNABLE TO INTERROGATE THE DEVICE. THE PATIENT WAS REFERRED TO NEUROSURGERY FOR A REPLACEMENT. THE DEVICE WAS REPLACED ON (B)(6) 2026. THE CAREGIVER CONFIRMED THE PATIENT HAD NO RECENT PROCEDURES THAT MAY HAVE DAMAGED THE RNS, BUT DID MENTION A FALL. THIS FALL OCCURRED AFTER THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PATIENT REPORTEDLY HIT THEIR HEAD THE DAY BEFORE THANKSGIVING AND RECEIVED STITCHES BUT DID NOT UNDERGO ANY OTHER MEDICAL PROCEDURES OR SURGERIES OUTSIDE OF THIS NEAR THE AREA OF THE DEVICE. CALLER NOTED THAT THEY DID NOT USE ANY ELECTROCAUTERY TO STOP THE BLEEDING FROM THE PATIENT'S FALL. PATIENT'S LAST INTERROGATION WAS ON 10/15/25 AND THEIR BATTERY VOLTAGE WAS AT 3.02V.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736770 ↗
• DeathMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH AN RNS SYSTEM (NEUROSTIMULATOR AND TWO THALAMUS DEPTH LEADS). ON 2/25/2026, NPCE WAS INFORMED THAT THE PATIENT HAD PASSED AWAY. PER THE SURGEON - THE PATIENT SUFFERED A LARGE POSTOPERATIVE SUBDURAL HEMATOMA AND CLINICAL RECOGNITION WAS DELAYED DUE TO HIS POOR BASELINE NEUROLOGIC STATUS ALONG WITH BASELINE ANISOCORIA. ONCE RECOGNIZED IT WAS URGENTLY SURGICALLY EVACUATED BUT UNFORTUNATELY, HE SUFFERED FROM SEVERE ISCHEMIC INJURY RELATED TO THE MASS EFFECT AND THE FAMILY ULTIMATELY OPTED FOR COMFORT MEASURES ONLY. THIS WAS A SURGICAL COMPLICATION DUE TO BLEEDING FROM I BELIEVE A BRIDGING VEIN THAT WAS PUT ON STRETCH DURING ELECTRODE PLACEMENT. I DO NOT FEEL THAT THIS WAS ANY DEVICE ISSUE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24699765 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SUSTAINING A FALL AROUND (B)(6) 2026. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE HOSPITAL AND UNDERWENT SURGICAL DRAINAGE OF THE INFECTED SITE. ACCORDING TO THE NEUROSURGICAL NOTE, TWO POCKETS OF PUS OVERLYING THE DEVICE WERE DRAINED. CULTURES GREW S. AUREUS. THE PATIENT WAS STARTED ON NAFCILLIN AND RIFAMPIN ON (B)(6) 2026. ON (B)(6) 2026 THE PATIENT HAD THEIR ENTIRE RNS SYSTEM EXPLANTED.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 24683556 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  MS. (B)(6) IS A 37 Y.O. WOMAN WITH FOCAL CORTICAL DYSPLASIA LEADING TO SEIZURES, TREATED WITH A NEUROSTIMULATION DEVICE WHO UNDERWENT AN EXPLANT ON (B)(6) 2025. SHE HAD A REIMPLANT ON (B)(6) 2025 DUE TO ISSUES WITH HER LEADS WHICH WAS COMPLICATED BY PURULENT DRAINAGE/SKIN BREAKDOWN AND HARDWARE EXPOSURE. SHE WAS TAKEN TO THE OR (B)(6) 2025 FOR WASHOUT AND A CLOSURE WITH PLASTIC SURGERY FOR A RETAINED DEVICE, TREATED WITH CEFTRIAXONE FOLLOWED BY AMOXICILLIN WITH CULTURES GROWING C ACNES. COMPLETED AMOXICILLIN (B)(6) 2025. NEUROPACE REPORTED THIS TO THE FDA THROUGH 3004426659 -2025-00046 / (B)(4). INTERVAL HISTORY THE PATIENT THEN DEVELOPED A RECURRENT CRANIAL WOUND BREAKDOWN/DRAINAGE AND WAS TAKEN FOR RNS NEUROSTIMULATOR REMOVAL ON (B)(6) 2025, FOLLOWED BY THE INPATIENT INFECTIOUS DISEASE CONSULTATION. CULTURES GREW S. EPIDERMIDIS AND C. ACNES SHE WAS INITIALLY TREATED WITH VANCOMYCIN BUT DEVELOPED LEUKOPENIA SO WAS SWITCHED TO DAPTOMYCIN. WHEN C. ACNES BEGAN TO GROW; IV PENICILLIN WAS ADDED FOR BETTER COVERAGE. THE PICC LINE HAD BEEN REMOVED AND SHE WAS PLACED ON ANTIBIOTIC SUPPRESSION WITH: DOXYCYCLINE 100MG BID FOR 24 DAYS AND AMOXICILLIN 1,000MG TID FOR 24 DAYS UNTIL (B)(6) 2025

  Patient problems: Bacterial Infection

  MAUDE report 24678692 ↗
• MalfunctionMar 16, 2026Failure to Interrogate

  THE PATIENT REPORTED FALLING ON (B)(6) 2026. AFTER THE FALL HE WAS UNABLE TO INTERROGATE HIS DEVICE. DURING CLINIC, THEY WERE UNABLE TO INTERROGATE HIS DEVICE AFTER MULTIPLE ATTEMPTS WE ARE WONDERING IF THE FALL COULD HAVE DAMAGED THE DEVICE. A CT WAS PERFORMED, THE RESULTS WERE UNREMARKABLE. ON (B)(6) 2026, THE RNS WAS REPLACED. NO VISIBLE DAMAGE WAS NOTED WITH ON THE BATTERY. THE RNS WAS RETURNED TO NEUROPACE AND IS UNDERGOING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610802 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  ON (B(6) 2026, THE OR CIRCULATOR NURSE AT DELL SETON NOTIFIED NPCE THAT THE PATIENT WOULD HAVE THEIR RNS SYSTEM (RNS DEVICE AND LEADS) EXPLANTED FOR INFECTION DETAILS OF THE EVENT WERE NOT PROVIDED. CULTURES WERE TAKEN; RESULTS WERE NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24512807 ↗