RNS® Neurostimulator Kit RNS-320-K (UDI 00855547005267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00855547005267), received between Aug 16, 2018 and Nov 5, 2025 — classified as 89 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (15 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  INVESTIGATION RESULTS: INVESTIGATION OF THE EXPLANTED NEUROSTIMULATOR HAS BEEN COMPLETED AND RESULTS ARE PROVIDED IN SECTION H10. ORIGINAL REPORT: THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2025 FOR A ROUTINE VISIT. PATIENT REPORTED THAT SHE WAS UNABLE TO DOWNLOAD OR COMMUNICATE WITH HER DEVICE. DURING THE CLINIC VISIT THE PROVIDER CONFIRMED THAT THE DEVICE WAS NOT COMMUNICATING. THE PROGRAMMER USED TO INTERROGATE THE DEVICE WAS CONFIRMED TO BE IN PROPER WORKING ORDER BY USE ON OTHER DEVICES SUCCESSFULLY. THERE WAS NO REPORT OF A PROCEDURE OR TRAUMA THAT COULD HAVE RESULTED IN AN UNRESPONSIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482686 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH AN EROSION AND PURULENT DISCHARGE AT THE NEUROSTIMULATOR SITE. THE PATIENT'S NEUROSTIMULATOR WAS EXPLANTED ON (B)(6) 2025. THE DEPTH LEADS AND BURR HOLE COVERS WERE EXPLANTED ON (B)(6) 2025. TREATMENT INCLUDED IV ANTIBIOTICS.

  Patient problems: Bacterial Infection; Erosion; Purulent Discharge

  MAUDE report 21548834 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT REPORTED TO THE EPILEPTOLOGIST, CONCERNS REGARDING AN INDENTATION AROUND THE RNS NEUROSTIMULATOR WITH PAIN/ THROBBING. THE EPILEPTOLOGIST REFERRED HER TO NEUROSURGERY FOR EVALUATION. ON (B)(6) 2024, ADDITIONAL SURGERY WAS PERFORMED BY PLASTICS AND NEUROSURGERY. THE PATIENT UNDERWENT SURGERY TO ADDRESS EROSION/ DEFECT OF THE PATIENT'S SKULL. TREATMENT INCLUDED THE USE OF PLATES TO BRIDGE ANY GAPS. NEUROSURGERY DECIDED TO REPLACE THE NEUROSTIMULATOR AT THE SAME TIME. TREATMENT INCLUDED STANDARD INTRA-OPERATIVE ANTIBIOTICS IN SITE AND INTRAVENEOUSLY.

  Patient problems: Erosion; Implant Pain

  MAUDE report 20622767 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD HIS RNS SYSTEM EXPLANTED (NEUROSTIMULATOR AND FOUR LEADS) ON (B)(6) 2024 TO TREAT INFECTION. NEUROPACE WAS MADE AWARE OF THIS EVENT ON 5/30/24. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2024. ONSET DATE WAS REPORTED TO BE ON 12/21/23 - DIAGNOSED AS A DEEP INCISIONAL INFECTION BY THE TREATING CENTER. THE PATIENT BEGAN SHOWING SIGNS OF INFECTION IN LATE (B)(6) 2023. THE PATIENT REPORTED THE INFECTION TO THE TREATING CENTER IN (B)(6) 2024. THE PHYSICIAN ATTEMPTED TO REMOVE THE INFECTION AT THE INCISION SITE BUT THE INFECTION HAD SPREAD SIGNIFICANTLY AND THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE DEVICE WITH LEADS AND BURR HOLE COVERS FOR SAFETY REASONS. THIS WAS DIAGNOSED AS A DEEP INCISIONAL INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 19834132 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED TO NEUROSURGERY WITH SCALP PAIN EARLIER IN JUNE. UPON INSPECTION, THERE WAS SCALP EROSION AND INFECTION OF THE AREA, WITH A LEAD EXTRUDING FROM SCALP. THE PATIENT UNDERWENT AN RNS SYSTEM EXPLANT (NEUROSTIMULATOR AND FOUR LEADS). ADDITIONAL DETAILS WERE NOT PROVIDED.

  Patient problems: Bacterial Infection; Erosion; Twiddlers Syndrome; Unspecified Infection

  MAUDE report 19751818 ↗
• MalfunctionJul 2, 2024Premature Discharge of Battery; Premature Discharge of Battery

  INVESTIGATION RESULTS PROVIDED IN H10. THE TREATING DOCTOR REPORTED THAT THE PATIENTS RNS NEUROSTIMULATOR DEVICE HAD REACHED AN EARLY END-OF-LIFE (EOL) AFTER 4.05 YEARS. THE DEVICE SETTINGS WERE NOT UNUSUAL AND DID NOT ACCOUNT FOR THE RAPID BATTERY DEPLETION. THE DEVICE WAS IMPLANTED ON (B)(6) 2020 AND REPLACED ON (B)(6) 2024. EVALUATION OF THE BATTERY PLOT IDENTIFIED THAT THE RNS NEUROSTIMULATOR'S BATTERY WAS IN THE BOTTOM 5TH PERCENTILE OF BATTERY VOLTAGE RELATIVE TO BATTERY DISCHARGE FOR MOST OF ITS LIFE. THE CAUSE IS UNABLE TO BE DETERMINED BY THIS INVESTIGATION. THE DEVICE WILL BE RETURNED TO NEUROPACE FOR INVESTIGATION OF THE ACTUAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658785 ↗
• MalfunctionMar 13, 2024Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  INVESTIGATION RESULTS PRESENTED IN SECTION H10 DURING A REVIEW OF THE PATIENT'S DEVICE DATA, IT WAS IDENTIFIED THE BATTERY WAS AT 2.35V AFTER 3.5 YEARS. THE SETTINGS ARE RELATIVELY STANDARD SETTINGS. THIS APPEARS TO BE AN EARLY BATTERY DEPLETION. NO DEFECTS WERE IDENTIFIED DURING THE PRODUCTION OF THE DEVICE, IT HAS BEEN MANUFACTURED AND RELEASED PER OUR SPECIFICATIONS. REVIEW OF THE DEVICE BATTERY BEHAVIOR: THE DEVICE APPEARS TO BE IN THE BOTTOM 5TH PERCENTILE OF BATTERY VOLTAGES COMPARED TO OTHER BATTERIES WITH SIMILAR CHARGE EXPENDITURES FOR ITS ENTIRE HISTORY. THIS IS UNUSUAL AND MAY BE INDICATIVE OF PREMATURE BATTERY DEPLETION. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896076 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RNS WAS IMPLANTED IN (B)(6) 2018. THE PATIENT DEVELOPED KLEBSIELLA OXYTOCA MENINGITIS AND HYDROCEPHALUS. THIS RESULTED IN EXPLANT OF THE RNS SYSTEM IN (B)(6) 2018. NO FURTHER DETAILS WERE PROVIDED BY THE TREATING FACILITY.

  Patient problems: Bacterial Infection; Hydrocephalus

  MAUDE report 18627459 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2018, THE PATIENT HAD A ROUTINE BATTERY REPLACEMENT. ON (B)(6)2018, THE PATIENT PRESENTED WITH EROSION, NO GROSS PURULENT DISCHARGE WAS REPORTED. ON (B)(6)2018, THE PATIENT UNDERWENT A REVISION OF THE INCISION SITE AT WHICH TIME THE NEUROSTIMULATOR AND FERRULE WERE REMOVED AND REPLACED WITH A NEW NEUROSTIMULATOR AND FERRULE. TREATMENT INCLUDED UNSPECIFIED IV ANTIBIOTICS. THIS WAS DIAGNOSED AS A DEEP INCISIONAL INFECTION. THE INFECTION RESOLVED AFTER TREATMENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18627458 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN RNS NEUROSTIMULATOR EXPLANT ON (B)(6) 2021 FOR INFECTION. NEUROPACE PERSONNEL WAS NOT PRESENT AT EXPLANT SO PROCEDURE DETAILS NOT KNOWN. ON (B)(6) 2021 ACCORDING TO PATIENT VISIT NOTES: THE PATIENT HAS DEVELOPED AN INFECTION AND WILL HAVE RNS EXPLANTED IN (B)(6) 2021, WITH A PLAN TO RE-IMPLANT IN 6 MONTHS IF ALL GOES WELL. PATIENT INITIALLY DEVELOPED A HEADACHE A WEEK AFTER THEIR INITIAL RNS IMPLANT, FOLLOWED BY MENINGITIS. DBS WAS THEN IMPLANTED AND PT WAS PLACED ON ANTIBIOTICS, AND STATED SHE WAS DOING BETTER. PATIENT STOPPED TAKING ANTIBIOTICS AND THE HEADACHE RETURNED IN MID (B)(6). IT APPEARS THAT THE INFECTION HAS RECURRED.

  Patient problems: Bacterial Infection

  MAUDE report 18582143 ↗
• MalfunctionNov 21, 2023Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  ORIGINAL REPORT- THE PATIENT HAD HER DEVICE PLACED IN MRI MODE AND THEN UNDERWENT AN MRI. FOLLOWING THE MRI, THE NEUROSTIMULATOR WOULD NOT COMMUNICATE WITH A PROGRAMMER NOR THE REMOTE MONITOR. ON (B)(6) 2023 THE NEUROSTIMULATOR WAS REPLACED AND RETURNED TO NEUROPACE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183483 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEW MONTHS AFTER IMPLANT THE PATIENT REPORTED SKULL PAIN. OVER THE YEARS HE OCCASIONALLY REPORTED SKULL PAIN, HEADACHES AND MORE RECENTLY PAIN THROUGHOUT HIS BODY. THE PATIENT WAS ADMITTED FOR EVALUATION. THE PATIENT REQUESTED THAT THE RNS BE REMOVED. ON (B)(6) 2023 THE PATIENT UNDERWENT A COMPLETE RNS SYSTEM EXPLANT (NEUROSTIMULATOR, LEADS, AND BURR HOLE COVERS). TREATMENT ALSO INCLUDED SURGICAL EVACUATION. THE DOCTOR REPORTED THE PATIENT SUFFERED SUBDURAL HEMORRHAGING FOLLOWING THE PROCEDURE. THE PATIENT WAS ADMITTED TO ICU ON (B)(6) 2023 FOR SUBDURAL HEMORRHAGE FOLLOWING EXPLANT. HE IS CURRENTLY INTUBATED AND HAS A FEEDING TUBE. THE CAUSE OF THE PATIENT'S PAIN WAS NOT DETERMINED.

  Patient problems: Headache; Intracranial Hemorrhage; Pain

  MAUDE report 17685884 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN OPEN RESECTION OF THE LEFT ANTERIOR MEDIAL TEMPORAL LOBE REGION ON (B)(6) 2023 WITH REVISION OF THE PRIOR PLACED BILATERAL HIPPOCAMPAL RNS (UNCHANGED ON RIGHT, ELECTRODE MOVED TO POSTERIOR MARGIN OF RESECTION ON THE LEFT). RNS DEVICE FUNCTIONED NORMALLY AFTER SURGERY. ON (B)(6)/2023, AFTER PRESENTING WITH PROGRESSIVE HEADACHE, CT REVEALED A LARGE LEFT HEMISPHERE SUBDURAL HEMATOMA (SDH), THE PATIENT UNDERWENT REOPENING OF THE LEFT HEMISPHERE CRANIOTOMY TO EVACUATE THE HEMATOMA. THE SDH EXTENDED OVER MUCH OF THE LEFT HEMISPHERE, INCLUDING UP TO THE ANTERIOR MARGIN OF THE RNS DEVICE LOCATION. PATIENT HAS BEEN DOING FINE SINCE THE EVACUATION OF HEMATOMA PROCEDURE, NO SEIZURES, NO SYMPTOMS.

  Patient problems: Headache; Hematoma

  MAUDE report 17121230 ↗
• InjuryMay 11, 2023Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  ORIGINAL REPORT: THE DEVICE REACHED AN EARLY END OF LIFE AFTER 3.06 YEARS. WHEN REVIEWING THE BATTERY PLOT, THE LAST PORTION OF THE PLOT LOOKED UNUSUAL. THE DEVICE WAS REPLACED ON (B)(6) 2023. THE DEVICE WAS RETURNED AND INVESTIGATED. INVESTIGATION RESULTS ARE NOW AVAILABLE, REFER TO SECTION H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913142 ↗
• InjuryApr 19, 2023Premature Discharge of Battery; Premature Discharge of Battery

  THE RNS NEUROSTIMULATOR (MODEL RNS-320) REACHED END OF LIFE (EOL) 3.3 YEARS AFTER INITIAL IMPLANT (B)(6) 2019. BATTERY LIFE EXPECTANCY IS USUALLY 6.0 - 12.4 YEARS WITH TYPICAL USE. WITH MEDIUM STIMULATION AND DETECTION SETTINGS THE BATTERY IS ESTIMATED TO LAST 10.8 YEARS. THE PATIENT UNDERWENT A NEUROSTIMULATOR REPLACEMENT ON (B)(6) 2022. THE DEVICE WAS RETURNED AND INVESTIGATED BY NEUROPACE. WHEN COMPARED TO EXPECTED BATTERY PLOT BEHAVIOR, THE BATTERY PLOT CURVE OF THE EXPLANTED DEVICE WAS OBSERVED TO BE DISCHARGING AT AN ABNORMALLY FAST RATE. THE SHAPE OF THE DISCHARGE CURVE WAS NORMAL, EXCEPT FOR DOWNWARD SPIKES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769934 ↗
• MalfunctionMar 16, 2023Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  DURING A ROUTINE FOLLOW-UP, THE PATIENT REPORTED HAVING ISSUES IN THE LAST COUPLE OF MONTHS WITH INTERROGATING AT HOME. MULTIPLE ATTEMPTS WERE MADE TO INTERROGATE THE DEVICE USING DIFFERENT PROGRAMMERS AND WANDS, ALL ATTEMPTS WERE UNSUCCESSFUL. THE RNS PROVIDED NO SIGNAL WHEN ATTEMPTING TO INTERROGATE. THE DEVICE APPEARS TO BE NONFUNCTIONAL. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT HAD A FALL IN (B)(6) OR (B)(6) 2022, RESULTING IN THE PATIENT HITTING HIS HEAD ON A WALL. THE PATIENT DID NOT GO TO THE HOSPITAL, NOR HAVE ANY IMAGING OR SURGERY AFTER THE FALL. THE RNS WAS REPLACED ON 08 NOV 2022.

  Patient problems: Fall

  MAUDE report 16559874 ↗
• MalfunctionFeb 14, 2023Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  ORIGINAL REPORT - THE PATIENT REPORTED THAT HE WAS UNABLE TO INTERROGATE HIS DEVICE AFTER EXPERIENCING A FALL. THE NEUROSTIMULATOR WAS REPLACED ON 1/16/23. A SIGNIFICANT DENT WAS NOTED ON THE TOP CAN OF THE NEUROSTIMULATOR WHEN IT WAS EXPLANTED. THE NEUROSTIMULATOR WAS RETURNED FOR INVESTIGATION. INVESTIGATION RESULTS: TESTING CONFIRMED AN INTERMITTENT CONNECTION IN THE PCA CIRCUIT. THIS PCA WAS SUBJECTED TO A SEVERE IMPACT TRANSMITTED FROM THE DEVICE CAN THROUGH THE INTERNAL FRAME. MOST PROBABLY THE IMPACT TO THE PCA CRACKED SOME NUMBER OF SOLDER BALL CONNECTIONS BETWEEN THE SDBGA AND THE PCA OR POSSIBLY TRACES IN THE PCB ITSELF WERE COMPROMISED. THE INTERMITTENT ELECTRICAL PERFORMANCE OF THIS PCA IS CONSISTENT WITH THE EXISTENCE OF INTERMITTENT CIRCUIT CONNECTIONS.

  Patient problems: Fall

  MAUDE report 16374661 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT SHE HAD GONE TO THE EMERGENCY ROOM (ER) (DATE NOT PROVIDED) DURING THIS VISIT, LABS AND A CT WERE ORDERED. ALL RESULTS WERE NORMAL. ON (B)(6) 2022, THE PATIENT CONTACTED THE APP TWICE AND SENT PICTURES OF THE PATIENTS SCALP SHOWING THE EXPOSED NEUROSTIMULATOR. ON (B)(6) 2022, THE PATIENT UNDERWENT AN EXPLANT OF THE RNS NEUROSTIMULATOR AND TWO DEPTH LEADS. THE PATIENT WAS DIAGNOSED WITH AN EPIDURAL INFECTION.

  Patient problems: Bacterial Infection; Erosion; Fluid Discharge

  MAUDE report 15695938 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH AN INFECTION, SKIN EROSION AND EXPOSED HARDWARE NEAR THE RNS NEUROSTIMULATOR IMPLANT ON (B)(6) 2022. THE PATIENT WAS DIAGNOSED WITH A DEEP INCISIONAL INFECTION. THE RNS SYSTEM (NEUROSTIMULATOR AND LEADS) WAS EXPLANTED ON (B)(6) 2022. THE PATIENT IS BEING TREATED WITH IV VANCOMYCIN, IV CEFOXITIN THROUGH (B)(6) 2022.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 15695142 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PHYSICIAN NOTIFIED NEUROPACE THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE NEUROSTIMULATOR SITE. THE ONSET DATE WAS REPORTED TO BE (B)(6) 2022. THE INFECTION DID NOT RESOLVE WITH ANTIBIOTICS. CONSEQUENTLY THE RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED ON (B)(6) 2022. DIAGNOSED AS A DEEP INCISIONAL INFECTION. THE INFECTION IS REPORTED AS BEING RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 15524380 ↗
• MalfunctionMay 4, 2022Premature Discharge of Battery; Premature Discharge of Battery

  THE NEUROSTIMULATOR WAS REPLACED ON (B)(6) 2022 FOR AN UNEXPECTED END OF LIFE. THE BATTERY PLOT VOLTAGE WAS OBSERVED TO DEPLETE PREMATURELY. INVESTIGATION OF THE NEUROSTIMULATOR DATA SUPPORT AN INTERPRETATION OF PREMATURE EARLY END OF SERVICE FOR THE DEVICE. AFTER EXPLANT THE TREATING CENTER DISCARDED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283327 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND TWO CORTICAL STRIP LEADS ON (B)(6) 2019. PATIENT PRESENTED TO EMERGENCY ROOM ON (B)(6) 2021 COMPLAINING OF A SUDDEN ONSET HEADACHE. IMAGING REVEALED A MODERATE SIZED RIGHT SIDED INTRAPARENCHYMAL HEMORRHAGE NEAR THE NEUROSTIMULATOR, AS WELL AS INTRAVENTRICULAR HEMORRHAGE. THE PATIENT HAD NO OTHER NEUROLOGICAL SYMPTOMS. THE PATIENT DENIED ANY HISTORY OF A TRAUMATIC INJURY, EXCESSIVE EXERTION, KNOWN GENERALIZED TONIC CLONIC SEIZURE, ANTICOAGULANT USE, HYPERTENSION, OR RECENT ILLNESS THAT COULD EXPLAIN THIS HEMORRHAGE. TREATMENT INCLUDED PROLONGED HOSPITALIZATION, MONITORING BY CT AND MRI, AND FREQUENT CLINICAL ASSESSMENTS, AS WELL AS PAIN MANAGEMENT.

  Patient problems: Headache; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13064827 ↗
• MalfunctionNov 22, 2021Failure to Interrogate; Failure to Interrogate

  INVESTIGATION RESULTS ARE NOW AVAILABLE. THE INITIAL REPORT INDICATED THE NEUROSTIMULATOR WAS UNRESPONSIVE AND REQUIRED EXPLANT. NEUROPACE RECEIVED THE EXPLANTED PRODUCT ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856013 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION AND SUBSEQUENT REMOVAL OF THE RNS SYSTEM PRODUCT WAS REPORTED TO NEUROPACE ON (B)(6) 2021 IT WAS RELAYED THAT THE PATIENT FIRST REPORTED WOUND DRAINAGE TO HER PRIMARY CARE DOCTOR ONLY, WHO THEN PLACED THE PATIENT OF ORAL ANTIBIOTICS. HOWEVER, AFTER COMPLETION OF THE ORAL ANTIBIOTICS THE WOUND DRAINAGE RESUMED. AT THAT TIME ((B)(6) 2021), THE PATIENT WAS ADMITTED TO STANFORD FOR IV ANTIBIOTIC TREATMENT AND WAS SUBSEQUENTLY DIAGNOSED WITH A DEEP INCISIONAL INFECTION. THE RNS SYSTEM PRODUCT (NEUROSTIMULATOR AND LEADS) WERE EXPLANTED ON (B)(6) 2021.

  Patient problems: Bacterial Infection

  MAUDE report 12821569 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PATIENT PRESENTED TO ER REGARDING SKIN BREAKDOWN OVER THE SURGICAL SITE AFTER RNS IMPLANT. THE PATIENT WAS HOSPITALIZED AND STARTED ON IV ANTIBIOTICS CEFEPIME AND VANOMYCIN. ON (B)(6) 2021 PATIENT UNDERWENT A WOUND WASHOUT. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 WITH VANCOMYCIN AND CEFTRIAXONE UNTIL (B)(6) 2021.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 12661347 ↗