NeuroPace® Depth Lead Kit DL-330-3.5-K (UDI 00855547005342)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00855547005342), received between Aug 5, 2022 and May 27, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Signal Artifact/Noise; High impedance

  IN (B)(6) 2024, HIGH IMPEDANCE AND SIGNAL ARTIFACT WAS OBSERVED ON THE PATIENT'S RIGHT MESIAL TEMPORAL DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION, ORTHOGONAL PLACEMENT). THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS. THE LEAD WAS TURNED OFF AT THAT TIME. ON (B)(6) 2026 THE RIGHT MESIAL TEMPORAL DEPTH LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306486 ↗
• MalfunctionMay 21, 2026Signal Artifact/Noise; High impedance

  AT THE (B)(6) 2025 DOCTOR APPOINTMENT, SIGNAL ARTIFACT WAS NOTED ON THE LEFT THALAMUS (CM) DEPTH LEAD, PLACED CONTRALATERAL TO THE RNS. THE LEAD IS SECURED WITH A DOG BONE WITH LEAD PROTECTION. STIMULATION WAS DISABLED ON THE LEAD AT THE (B)(6) 2025 APPOINTMENT. HIGH IMPEDANCE WAS NOTED IN (B)(6) 2026 ON THE SAME LEAD. SIGNAL ARTIFACT AND HIGH IMPEDANCE ARE INDICATIVE OF A LEAD BREAK. THE LEAD WAS REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249711 ↗
• MalfunctionApr 9, 2026Signal Artifact/Noise

  REVIEW OF THE PATIENT ECOG IDENTIFIED FLAT SIGNAL ON THE RIGHT THALAMUS (CM) DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION. ON (B)(6) 26, THE LEAD WAS REPLACED. DURING THE EXPLANT PROCESS, THE SURGEON NOTED A POTENTIAL AREA OF DAMAGE ON THE CURVED PART OF THE LEAD, WHERE IT WAS RESTING ON THE BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832397 ↗
• InjuryMar 10, 2026Device Slipped; Detachment of Device or Device Component

  THE TREATING FACILITY REPORTED THE PATIENT HAD A SMALL BUMP CLOSE TO THE INCISION SITE. A CT SHOWED THE DOG BONE AND LEAD WERE INTACT AND CORRECTLY PLACED, SO IT WAS SUSPECTED THE LEAD PROTECTOR OF THE LEFT OCCIPITAL DEPTH LEAD HAD SLIPPED OUT FROM UNDER THE DOG BONE. ON (B)(6) 2026, AN ADJUSTMENT WAS MADE TO THE LEAD FIXATION. THE PLASTIC LEAD PROTECTOR HAD SLIPPED FROM UNDER THE DOG BONE, CAUSING A BUMP UNDER THE SCALP. THE SURGEON FIXED THE ISSUE WITH NO COMPLICATIONS TO THE LEAD. THE DOG BONE AND LEAD PROTECTOR WERE REVISED TO PREVENT FURTHER SLIPPAGE WITH NO COMPLICATIONS.

  Patient problems: Nodule

  MAUDE report 24564621 ↗
• MalfunctionFeb 23, 2026Signal Artifact/Noise

  ON (B)(6) 2025, SIGNAL ARTIFACT WAS OBSERVED ON THE LEFT PARIETAL DEPTH LEAD. THE LEAD WAS SECURED WITH A DOG BONE WITH LEAD PROTECTION. NO PROGRAMMING CHANGES WERE MADE. ON (B)(6) 2026, THERAPY WAS DISABLED ON THE AFFECTED ELECTRODES (LEAD 1/ ELECTRODES 3 AND 4). ON (B)(6) 2026 THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423096 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem; Migration

  THE PATIENT UNDERWENT SEEG IN 2022, AND UNFORTUNATELY SUFFERED A HEMORRHAGIC STROKE AS A COMPLICATION. THE PATIENT WAS IMPLANTED WITH THE RNS SYSTEM ON (B)(6) 2023. THIS WAS ABOUT 6 MONTHS AFTER THE HEMORRHAGE. POST-OPERATIVE IMAGING SHOWED AN EPIDURAL HEMATOMA UNDER THE NEUROSTIMULATOR. A SURGICAL EVACUATION OF THE HEMATOMA WAS DONE AT THAT TIME. THE PATIENT DID HAVE SOME DEFICITS AFTER THIS COMPLICATION (DYSARTHRIA). IN (B)(6) 2025, THE PATIENT WAS ASSESSED BY THE TREATING PHYSICIAN AND WAS FOUND TO HAVE WORSENING DYSARTHRIA. A HEAD CT WAS DONE, WHICH REVEALED MIGRATION OF THE LEFT FRONTOPARIETAL DEPTH LEAD. THE TREATING PHYSICIAN REPORTED THAT IT IS UNCLEAR WHETHER THE LEAD MIGRATED AS A RESULT OF ATROPHY OF THE BRAIN TISSUE RELATED TO THE PREVIOUS HEMOATOMA/HEMORRHAGE, BUT FEELS THIS IS A POSSIBILITY. THE PATIENT HAD BEEN FOLLOWING WITH ANOTHER PROVIDER WHO HAD BEEN GETTING SERIAL HEAD CTS. THE TREATING PHYSICIAN REVIEWED THE SERIAL HEAD CTS AND FOUND THAT THE POSITION OF THE DEPTH LEAD HAS BEEN STABLE SINCE (B)(6) 2024. FOR NOW, STIMULATION REMAINS ON.

  Patient problems: Hematoma; Intracranial Hemorrhage; Memory Loss/Impairment

  MAUDE report 24402219 ↗
• InjuryJan 27, 2026Signal Artifact/Noise; High impedance

  LEAD ARTIFACT AND HIGH IMPEDANCES WERE INITIALLY OBSERVED IN (B)(6) 2023, ON THE RIGHT THALAMIC DEPTH LEAD. THE LEAD WAS INITIALLY SECURED WITH A HEMOCLIP WITH NO LEAD PROTECTION. THE LEAD WAS REPLACED AND SECURED WITH A BURR HOLE COVER ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189313 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT PRESENTED WITH AN INFECTION NEAR THE BURR HOLE COVER FOR THE RIGHT INSULA DEPTH LEAD. ON (B)(6) 2025, THE LEAD AND BURR HOLE COVER WERE EXPLANTED. TREATMENT INCLUDED ORAL CLINDAMYCIN AND IV VANCOMYCIN TO TREAT THE SUPERFICIAL INCISIONAL INFECTION AND DEHISCENCE. CULTURES WERE PERFORMED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24015217 ↗
• MalfunctionDec 10, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  DURING REVIEW OF THE PATIENT ECOG DATA, THE RIGHT THALAMUS (ANT) DEPTH LEAD (SECURED WITH A SUTURE TO THE DURA) IDENTIFIED SIGNAL ARTIFACT AND UNMEASURED IMPEDANCES INDICATIVE OF A LEAD BREAK. ON (B)(6) 2025, THE LEAD DETECTION AND STIMULATION WAS TURNED OFF. ON (B)(6) 2025, THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774476 ↗
• MalfunctionDec 2, 2025Migration; Migration

  PATIENT APPOINTMENT SUMMARY - (B)(6) 2025 DURING THE APPOINTMENT, THE PATIENT'S FAMILY REPORTED OBSERVING AN INVOLUNTARY RIGHT ELBOW MOVEMENT RESEMBLING A "CHICKEN WING," WHICH THEY INITIALLY SUSPECTED TO BE A SEIZURE. THE PATIENT WAS LAST PROGRAMMED ON (B)(6) 2024, AND THESE MOVEMENTS WERE FIRST NOTED IN (B)(6) 2025. UPON EVALUATION, THE PHYSICIAN TESTED STIMULATION AND CONFIRMED THAT THE PATIENT'S RIGHT ELBOW CONSISTENTLY EXTENDED DURING THERAPY DELIVERY. THE PATIENT'S DEVICE WAS PROGRAMMED WITH THE MOST DISTAL CONTACT ON THE LEFT LEAD TURNED OFF. THE PHYSICIAN EXPRESSED CONCERN THAT THE LEFT LEAD MAY HAVE SHIFTED, AS THIS PHENOMENON WAS NOT PRESENT PREVIOUSLY AND DID NOT OCCUR IMMEDIATELY FOLLOWING THE (B)(6) LAST PROGRAMMING. SURGICAL INTERVENTION - (B)(6) 2025 THE PATIENT UNDERWENT A REPOSITIONING REVISION OF THE LEFT THALAMUS (CM) DEPTH LEAD. INTRAOPERATIVELY, THE SURGEON NOTED SIGNIFICANT SOFT TISSUE AT THE FIXATION SITE, WHICH COMPROMISED THE STABILITY OF THE DOG BONE. TO IMPROVE LEAD STABILITY, THE SURGEON INVERTED THE DOG BONE DURING THE PROCEDURE.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 23694410 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT ARRIVED AT THEIR APPOINTMENT WITH A BUMP ON THE RIGHT SIDE OF THEIR HEAD. AN MRI WAS PERFORMED. MRI REVEALED A CSF LEAK NEAR THE RIGHT ELECTRODE TO THE SURFACE OF THE BRAIN. TREATMENT IS PENDING. PHYSICIAN TEAM IS CONSIDERING A SHUNT FOR CSF DRAINAGE IF PATIENT HAS HYDROCEPHALUS. THE PATIENT IS CURRENTLY HOSPITALIZED. ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN (DR. DEBORAH HOLDER). IT APPEARS IN REVIEWING OLD FILMS THAT THE TREATING CENTER RECEIVED FROM UCLA THAT HER HYDROCEPHALUS HAS BEEN SLOWLY PROGRESSIVE FOR MANY YEARS, WELL BEFORE THE RNS SYSTEM IMPLANT. DR. BONDA SUGGESTED THE RNS DEPTH LEAD WENT THROUGH A LARGE PERIVASCULAR SPACE AND CONNECTED TO HER VENTRICULAR SYSTEM THAT THEN WITH THE INCREASED PRESSURE RESULTED IN THE FLUID AROUND THE ELECTRODE.

  Patient problems: Cerebrospinal Fluid Leakage; Swelling/ Edema

  MAUDE report 23077430 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ONSET DATE WAS REPORTED AS 4/22/25. THE PATIENT PRESENTED WITH EROSION, EXPOSING THE LEFT THALAMIC DEPTH LEAD. THE LEAD WAS NOT ACTIVE AND NOT CONNECTED TO THE NEUROSTIMULATOR. ON (B)(6) 2025, THE SURGICAL TEAM PERFORMED A WOUND WASHOUT AND REMOVED A PORTION OF THE EXPOSED LEAD. THE PLASTIC SURGERY TEAM ASSISTED WITH WOUND CLOSURE. THE PATIENT WAS TREATED WITH UNSPECIFIED ORAL ANTIBIOTICS FOR ONE WEEK. THE CAUSE WAS ATTRIBUTED TO THE PATIENT PICKING AT THE LEAD SITE. THE RNS SYSTEM REMAINS INTACT AND FUNCTIONING.

  Patient problems: Erosion; Twiddlers Syndrome

  MAUDE report 22197391 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT PRESENTED TO THE (B)(6) EMERGENCY ROOM WITH NAUSEA, VOMITING, AND A DECREASED LEVEL OF CONSCIOUSNESS. A CT SCAN WAS PERFORMED AND SHOWED A LARGE LEFT FRONTAL HEMATOMA IN THE AREA OF THE LEFT THALAMUS (CM) DEPTH LEAD. SURGICAL EVACUATION OF THE HEMATOMA WAS PERFORMED. THE LEFT NEUROSTIMULATOR WAS REMOVED TO VISUALIZE AND TREAT THE BLOOD CLOT ON THE SURFACE. THE NEUROSTIMULATOR WAS THEN REPLACED. THERE WAS NO REPORT OF A FALL OR TRAUMA. THE POST-OP CT SCAN SHOWED FULL EVACUATION OF THE HEMATOMA. THE PATIENT IS NO LONGER HOSPITALIZED AND THE HEMATOMA IS NOW RESOLVED.

  Patient problems: Decreased Level of Consciousness; Hematoma; Nausea

  MAUDE report 21659739 ↗
• MalfunctionMar 17, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6)2025, A REVIEW OF THE PATIENT DEVICE ECOG DATA IDENTIFIED SIGNAL ARTIFACT ON THE RIGHT THALAMUS (CM) DEPTH LEAD SECURED WITH A DOG BONE AND LEAD PROTECTION. DEVICE ASSESSMENT INCLUDED REVIEWING STORED ECOGS AND PALPATING THE LEAD CONNECTION THROUGH THE SKIN, WHILE MONITORING LIVE ECOG DATA. A LONG EPISODE ECOG STORED ON (B)(6) 2024, WAS WHEN THE FIRST CLEAR ARTIFACT WAS NOTED. ON (B)(6) 2025, IN CLINIC, DETECTION WAS REPROGRAMMED (ELECTRODE WHERE ARTIFACT WAS RECORDED WAS PROGRAMMED TO 'OFF'). STIMULATION PARAMETERS WERE NOT CHANGED. ALTHOUGH THE CAUSE OF THE LEAD BREAK IS UNDETERMINED, THE PATIENT REPORTED A SEIZURE ON (B)(6) 2024, AND THIS SEIZURE WAS VERIFIED BY THE DEVICE RECORDING OF THE LONG EPISODE ECOG. THE PATIENT HAS A HISTORY OF HITTING THEIR HEAD DURING SEIZURES. ON (B)(6)2025, THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627644 ↗
• MalfunctionJan 27, 2025Mechanical Problem; Device Slipped; Unintended Movement; Mechanical Problem; Device Slipped; Unintended Movement

  ON (B)(6) 2025, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S EYES WERE CROSSING. ON (B)(6) 2025, A CT SCAN WAS PERFORMED. WHEN THE STIMULATION WAS TURNED OFF FOR THE PROCEDURE, THE EYE TURNING STOPPED. THE PATIENT'S EPILEPTOLOGIST CONFIRMED THE PATIENT'S LEFT THALAMUS (CM) DEPTH LEAD HAD MIGRATED. THE MIGRATION MAY HAVE RESULTED IN STIMULATION AND DETECTION NOT BEING DELIVERED AT THE INTENDED LOCATION. ON (B)(6) 2025 THE PATIENT UNDERWENT A LEAD REPOSITIONING. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE LEAD WAS LOOSE AT THE DOG BONE. THE LEAD WAS PULLED BACK. THERE HAS BEEN MENTION THAT THE PATIENT MAY HAVE EXPERIENCED A FALL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21241579 ↗
• MalfunctionDec 26, 2024Signal Artifact/Noise; High impedance; Impedance Problem; Signal Artifact/Noise; High impedance; Impedance Problem

  THE LEFT THALAMUS (CM) DEPTH LEAD WAS REPLACED ON (B)(6) 2024 AFTER ARTIFACT AND HIGH IMPEDANCE WERE OBSERVED DURING AN ECOG REVIEW IN (B)(6)2023. A PROGRAMMING CHANGE WAS MADE AT THAT TIME; THE CONTACTS INVOLVED WITH THE HIGH IMPEDANCES WERE TURNED OFF. THE PATIENT WAS SCHEDULED FOR A NEUROSTIMULATOR REPLACEMENT TO ADDRESS ROUTINE END OF LIFE IN (B)(6) 2024 AND THE LEAD REPLACEMENT WAS PERFORMED AT THIS SAME TIME. THE CAUSE OF THE BREAK WAS POSSIBLY RELATED TO THE CLIP THAT WAS USED TO SECURE THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023393 ↗
• MalfunctionJun 28, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ARTIFACT AND HIGH IMPEDANCE WAS SEEN ON THE ECOGS STARTING IN (B)(6) 2024, AND WHEN IMPEDANCES WERE CHECKED, CONTACT 1 HAD A HIGH IMPEDANCE COMPARED TO THE OTHER THREE CONTACTS. THE LEAD WAS REPLACED ON (B)(6) 2024. THE EPILEPTOLOGIST SUSPECTS THE HEMACLIP USED IN SURGERY TO SECURE THE LEAD IN PLACE COULD BE THE CAUSE FOR THE LEAD BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633350 ↗
• MalfunctionJun 27, 2024Impedance Problem; Impedance Problem

  ON (B)(6) 2024, DURING CLINIC, NO IMPEDANCE VALUES WERE OBSERVED ON THE RIGHT CENTRAL MEDIAN (RCM) DEPTH LEAD. THE TREATING CENTER DISABLED STIMULATION AND DETECTION ON THE RCM AT THAT TIME. A LEAD REVISION WAS PERFORMED ON (B)(6) 2024. LEAD BREAK CAUSE MIGHT BE RELATED TO A FALL THE PATIENT EXPERIENCED AS A RESULT OF A SEIZURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625719 ↗
• MalfunctionJan 4, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2022 THE PHYSICIAN OBSERVED UNUSUAL ECOG DATA INVOLVING THE TWO IMPLANTED DEPTH LEADS INDICATIVE OF LEAD BREAKS. THE PATIENT HAD TWO SEPARATE FALLS THAT IMPACTED THE RIGHT SIDE OF THE HEAD. ONE FALL OCCURRED AROUND (B)(6) 2021. THE SECOND FALL OCCURRED AROUND (B)(6) OR (B)(6) 2022. BOTH FALLS CAUSED TRAUMA TO THE SCALP, REQUIRING STITCHES. THE PATIENT UNDERWENT A LEAD REVISION ON (B)(6) 2022. DURING THE REVISION, THE CONNECTOR COVER WAS NOTED TO BE BROKE AND BOTH LEADS HAD VISIBLE DAMAGE. THE PATIENT WAS REIMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS CURRENTLY PROGRAMMED FOR DETECTION ONLY. A FOLLOW UP APPOINTMENT HAS BEEN SCHEDULED FOR THE END OF DECEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097392 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2022. THE TREATING CENTER NOTIFIED NEUROPACE ON (B)(6) 2022 THAT THE PATIENT HAS PERI-ELECTRODE EDEMA AROUND THE RIGHT DEPTH ELECTRODE. STEROIDS WERE STARTED ON (B)(6) 2022. PATIENT PRESENTED WITH HEADACHES, SOMNOLENCE, REFRACTORY NAUSEA AND VOMITING. THE TREATING CENTER REPORTS THE PATIENT IS BACK TO BASELINE. THERE IS NO CONCERN FOR ANY LONG TERM SEQUELA.

  Patient problems: Headache; Nausea; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 15983421 ↗
• MalfunctionAug 5, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  THE TREATING CENTER IDENTIFIED UNUSUAL IMPEDANCES ON THE LEAD DURING A PATIENT ECOG REVIEW. WHEN THE PATIENT'S HEAD WAS PALPATED; THERE WAS VISIBLE ARTIFACT OBSERVED ON THE ECOG. DURING THE NEUROPACE INVESTIGATION OF THE ECOG DATA, WE OBSERVED ARTIFACTS AND HIGH IMPEDANCES ON LEAD 2, INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE LEAD WAS SECURED WITH A DOG BONE AND LEAD PROTECTOR. LEAD WAS IMPLANTED FOR 0.6 YEARS. THERE WAS NO IDENTIFIED CAUSE OF THE LEAD BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179088 ↗