NeuroPace® Depth Lead Kit DL-344-3.5-K (UDI 00855547005359)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00855547005359), received between Dec 14, 2023 and Apr 21, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Signal Artifact/Noise; High impedance

  ON (B)(6) 2024, REVIEW OF THE PATIENT DATA INDICATED HIGH IMPEDANCE AND SIGNAL ARTIFACT WHICH WERE INDICATIVE OF A LEAD BREAK. ON (B)(6) 2026, THE RIGHT THALAMUS (PUL) DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION) PLACED CONTRALATERAL TO THE RNS WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947696 ↗
• MalfunctionFeb 5, 2026Signal Artifact/Noise; High impedance

  THE RIGHT THALAMUS (CM) DEPTH LEAD, WHICH WAS LOCATED CONTRALATERAL TO THE RNS AND SECURED WITH A DOG BONE AND LEAD PROTECTION, DEMONSTRATED EVIDENCE OF A LEAD BREAK. IT WAS EXPLANTED ON (B)(6) 2026. THE LEAD HAD SHOWN SATURATIONS AND SIGNAL ARTIFACT ON THE ECOG DATA. INITIAL INTERVENTIONS INCLUDED SCALP PALPATION AND A PROGRAMMING ADJUSTMENT. DURING THE REVISION PROCEDURE, THE SURGICAL TEAM NOTED THAT THE LEAD WAS KINKED IN THE AREA WHERE THE EXCESS LEAD LENGTH HAD BEEN COILED NEAR THE GENERATOR. FOR THE REPLACEMENT, THE PHYSICIAN SELECTED A SHORTER LEAD TO MINIMIZE EXCESS LENGTH AND REDUCE THE RISK OF FUTURE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268955 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING CENTER REPORTED THAT THE PATIENT'S INCISION DID NOT HEAL AROUND THE BURR HOLE SITE. THE SKIN WAS OPEN, AND THE BURR HOLE VISIBLE. ON (B)(6) 2026 THE BURR HOLE COVER AND LEAD WERE REMOVED. THE SUPERFICIAL INFECTION WAS TREATED WITH ORAL KEFLEX AND AUGMENTIN.

  Patient problems: Bacterial Infection; Impaired Healing

  MAUDE report 24248136 ↗
• InjuryJan 27, 2026Signal Artifact/Noise; High impedance

  LEAD ARTIFACT AND HIGH IMPEDANCES WERE INITIALLY OBSERVED IN (B)(6) 2023, ON THE LEFT 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 24189312 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FEELING THAT "THINGS WERE OFF" PRIOR TO ADMISSION ON (B)(6) 2025. ACCORDING TO THE PATIENT'S SPOUSE, SYMPTOMS BEGAN APPROXIMATELY TWO WEEKS BEFORE HOSPITALIZATION AND WERE CHARACTERIZED BY SLURRED SPEECH AND WORD-FINDING DIFFICULTIES, INDICATIVE OF IMPAIRED SPEECH. THE EXACT ONSET DATE WAS NOT PROVIDED. THESE SYMPTOMS REPORTEDLY WORSENED DURING HOSPITALIZATION. ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR AN INTRACRANIAL HEMORRHAGE MEASURING APPROXIMATELY 18 MM, LOCATED NEAR THE RIGHT DEPTH LEAD IMPLANTATION SITE. REVIEW OF ECOG DATA INDICATED AN INCREASE IN LONG-EPISODE ACTIVITY BETWEEN (B)(6) AND (B)(6), WHICH THE HEALTHCARE PROVIDER SUSPECTS MAY BE ASSOCIATED WITH THE HEMORRHAGE. NO MEDICAL INTERVENTION WAS PERFORMED DURING HOSPITALIZATION. AN MRI APPEARS TO HAVE BEEN CONDUCTED ON (B)(6) 2025, BASED ON AVAILABLE PATIENT DATA; HOWEVER, RESULTS WERE NOT PROVIDED. THE PATIENT DEMONSTRATED CLINICAL IMPROVEMENT ON THE FINAL DAY OF HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2025. THE ETIOLOGY OF THE HEMORRHAGE REMAINS UNDETERMINED. (B)(6) 2025 DURING A FOLLOW UP THE PATIENT SHOWED SUBSTANTIAL IMPROVEMENT TO ALMOST RESOLUTE IMPROVEMENT. THE PATIENT CONTINUES TO R

  Patient problems: Headache; Intracranial Hemorrhage; Speech Disorder

  MAUDE report 23694412 ↗
• MalfunctionJun 16, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  ARTIFACT SIGNAL WAS OBSERVED ON THE PATIENT ECOG AROUND (B)(6) 2024. HIGH IMPEDANCE WAS ALSO OBSERVED ON THE LEFT THALAMUS CENTRAL MEDIAN (LCM) LEAD CONTACT 1 AND 2. A PROGRAMMING CHANGE WAS MADE ON (B)(6) 2024 TO DISABLE STIMULATION ON THE LCM LEAD. THE LEAD WAS REPLACED ON (B)(6) 2025. DAMAGE WAS OBSERVED ON THE EXPLANTED LEAD JUST DISTAL OF THE ENTRY POINT INTO THE SKULL/ PROTECTIVE SLEEVE. THE LEAD HAD BEEN SECURED WITH A DOG BONE WITH LEAD PROTECTION. THERE WAS NO REPORTED FALL OR TRAUMA WHICH COULD HAVE CONTRIBUTED TO THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216276 ↗
• 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 21023533 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2024 WITH BILATERAL DEPTH LEADS CM OF THE THALAMUS. AFTER THE FIRST FOLLOW UP VISIT ON OR AROUND (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL. MRI AND CT SCANS WERE ORDERED. DIAGNOSTIC SCAN RESULTS WERE NOT PROVIDED. A SPINAL TAP DID NOT IDENTIFY AN INFECTION. THE TREATING PHYSICIAN REPORTS SYMPTOMATIC (L) LEAD EDEMA. TREATMENT INCLUDES HOSPITALIZATION AND STEROIDS. THE PATIENT CONTINUES TO BE EVALUATED.

  Patient problems: Cerebral Edema; Swelling/ Edema

  MAUDE report 20507650 ↗
• MalfunctionAug 20, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ON (B)(6) 2024, NEUROPACE AND THE TREATING DOCTOR OBSERVED AN IMPEDANCE ISSUE ON THE DEPTH LEAD LOCATED IN THE RIGHT ANTERIOR THALAMUS. LIVE RECORDING SHOWED HIGH IMPEDANCES AND IMPEDANCES READING "UNABLE TO MEASURE." THE TIMING OF THIS CHANGE ALIGNS WITH A FALL REPORTED BY A PATIENT. THE PHYSICIAN SUSPECTED A LEAD FRACTURE. A LEAD REVISION WAS COMPLETED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001948 ↗
• MalfunctionJun 28, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ON 07/25/2024, DURING REVIEW OF THE PATIENT ECOG DATA HIGH IMPEDANCE AND ABNORMAL SIGNALS WERE NOTED ON THE 2ND CONTACT ON THE RIGHT LEAD. NO CHANGES WERE MADE TO THE PROGRAMMING AT THAT TIME. THE LEAD WAS REPLACED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633315 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND FOUR LEADS. ON (B)(6) 2024 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DIFFICULTY WITH WORD FORMING. HEMORRHAGING WAS IDENTIFIED TO BE NEAR TWO OF THE LEFT PARIETAL (LPAR) LEAD ELECTRODES AND A QUESTIONABLE HEMORRHAGE NEAR THE BURR HOLE COVER. THE PATIENT WAS PRESCRIBED SEVEN (7) DAYS OF STEROIDS. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT RECEIVED ANOTHER FIVE (5) DAY COURSE OF STEROIDS. THE APHASIA RESOLVED AFTER THE SECOND COURSE OF STEROIDS. THE PATIENT WAS SEEN ON (B)(6) 2024, THE SYMPTOMS HAVE RESOLVED. THE PATIENTS RNS SYSTEM IS NOW PROGRAMMED FOR DETECTION AND STIMULATION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19522036 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/13/23 THE PATIENT PRESENTED WITH A LARGE SCAB AT FRONTAL PORTION OF INCISION SITE, A SCAB WAS LOOSENED BY A RECENT FALL. THERE WAS AN ATTEMPT AT CONSERVATIVE MANAGEMENT WITH DEHISCENCE OF INCISION APPROXIMATELY 1 WEEK LATER. TREATMENT INCLUDED ANTIBIOTICS AND SURGERY FOR WOUND WASHOUT/ RECLOSURE. ORAL ANTIBIOTICS WERE PROVIDED FOR 10 DAYS POST SURGERY. THE DEVICE REMAINS IMPLANTED. DIAGNOSED AS SUPERFICIAL INCISIONAL INFECTION. PATIENT HAS RECOVERED.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 18331055 ↗