RNS Neurostimulator KitRecalls & reported problems across all models
Neuropace, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 431
- Deaths reported
- 2
- Injuries reported
- 388
- Recalls
- 0
We found 3 models of RNS Neurostimulator Kit by Neuropace, Inc. in the FDA's device registry (GUDID). Together they are named in 431 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2015 and Jul 8, 2026 — classified as 2 deaths, 388 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RNS Neurostimulator Kit problems
Device problems
- Adverse Event Without Identified Device or Use Problem382
- Failure to Interrogate32
- Communication or Transmission Problem23
- Premature Discharge of Battery10
- Failure to Transmit Record7
- Device Remains Activated4
- Battery Problem2
- High impedance2
Patient problems
- Bacterial Infection149
- Unspecified Infection106
- Wound Dehiscence56
- Erosion44
- Fluid Discharge37
- No Clinical Signs, Symptoms or Conditions33
- Impaired Healing28
- Purulent Discharge27
RNS Neurostimulator Kit models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RNS® Neurostimulator Kit RNS-320-KImplanted brain stimulator for epilepsy2 deaths218 reports
- RNS® Neurostimulator Kit RNS-320-KImplanted brain stimulator for epilepsy108 reports
- RNS® Neurostimulator Kit RNS-300M-KImplanted brain stimulator for epilepsy105 reports
Recent RNS Neurostimulator Kit adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Neuropace, Inc. products
All Neuropace, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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