NeuroPace® Depth Lead Kit DL-330-10-K (UDI 00855547005335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00855547005335), received between Aug 22, 2022 and Jul 14, 2026 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Signal Artifact/Noise; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813524 ↗
• MalfunctionJun 30, 2026Signal Artifact/Noise; High impedance

  IN FEB 2026, REVIEW OF THE PATIENT ECOG DATA IDENTIFIED SIGNAL ARTIFACT AND HIGH IMPEDANCE ON THE LEFT AMYGDALA DEPTH LEAD, SECURED WITH A DOG BONE WITH LEAD PROTECTION, INDICATIVE OF A LEAD BREAK. ON (B)(6) 2026, THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670892 ↗
• MalfunctionJun 18, 2026Signal Artifact/Noise; High impedance

  ON (B)(6) 2026, REVIEW OF THE PATIENT'S ECOG DATA WAS PERFORMED. THERE WAS EVIDENCE OF A LEAD BREAK ON THE RIGHT MESIAL TEMPORAL DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION, IN THE FORM OF HIGH IMPEDANCES AND FLAT SIGNALS. ON (B)(6) 2026, STIMULATION ON THE RIGHT LEAD WAS TURNED OFF ON (B)(6) 2026. THE LEAD WAS REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550916 ↗
• InjuryJun 16, 2026Signal Artifact/Noise

  ON (B)(6) 2025, SIGNAL ARTIFACTS AND INCREASES IN SATURATIONS WERE OBSERVED ON THE LEFT FRONTAL DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION, PLACED CONTRALATERAL TO THE RNS. PROGRAMMING CHANGES WERE MADE AT THIS TIME. ON (B)(6) 2026, THE LEAD WAS REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523809 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise

  IN (B)(6) 2025, UNUSUAL SIGNAL WAS OBSERVED ON THE PATIENT'S RIGHT HIPPOCAMPAL DEPTH LEAD, MOST NOTICEABLY FLATNESS TO THE BLOCK SIGNAL, WHICH IS INDICATIVE OF A LEAD BREAK. THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS, AND HIS LAST CLINICAL SEIZURE WAS REPORTED TO HAVE BEEN IN MID-NOVEMBER, BUT IT WAS VERY BRIEF. TROUBLESHOOTING DURING THE CLINIC VISIT (INCLUDED PRESSING ON THE DEVICE), WAS ABLE TO REPLICATE THE SIGNAL SOMEWHAT WITH EACH PRESS DOWN. NO CHANGE IN PROGRAMMING WAS MADE AT THAT TIME. ON (B)(6) 2026 THE MESIAL TEMPORAL HIPPOCAMPAL RIGHT DEPTH LEAD (SECURED WITH A DOG BONE WITH LEAD PROTECTION, LONGITUDINAL PLACEMENT) WAS EXPLANTED. THE LEAD WAS NOTICED TO BE VISIBLY KINKED DURING THE EXPLANT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233985 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise; High impedance

  IN (B)(6) 2024, ARTIFACT AND HIGH IMPEDANCE WAS OBSERVED ON THE PATIENTS RIGHT MESIAL TEMPORAL DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION, ORTHOGONAL APPROACH). THE PATIENT DID NOT REPORT ANY FALLS OR ACCIDENTS. PROGRAMMING CHANGES WERE MADE IN (B)(6) 2024. ON (B)(6) 2026 THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233979 ↗
• MalfunctionApr 9, 2026Signal Artifact/Noise; High impedance

  THE PATIENT REPORTED HE HAD AN ACCIDENT ON HIS BIKE AND THAT HE HIT HIS HEAD. THE LEFT MESIAL TEMPORAL DEPTH LEAD (LONGITUDINAL APPROACH, CONTRA LATERAL TO THE RNS, SECURED WITH DOG BONE WITH LEAD PROTECTION) SHOWED HIGH IMPEDANCES DURING ECOG REVIEW. AN X-RAY SHOWED NO OBVIOUS LEAD ISSUES. THE LEAD WAS REPLACED ON (B)(6) 2026. THE SURGEON NOTED VISIBLE DAMAGE DURING THE EXPLANT PROCESS. THE LEAD WAS DAMAGED DURING THE EXPLANT PROCESS AND WILL NOT BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834769 ↗
• MalfunctionApr 9, 2026Signal Artifact/Noise; High impedance

  ON (B)(6) 2024, SIGNAL ARTIFACT WAS NOTED ON CHANNEL 3 AND 4, AND HIGH IMPEDANCES ON CONTACTS 1 AND 4 OF THE LEFT TEMPORAL (NON-MESIAL) DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION), INDICATING A POSSIBLE LEAD BREAK. THE LEAD WAS REPLACED ON (B)(6) 2026. THE TREATING PHYSICIAN REPORTED THAT THE CAUSE MAY HAVE BEEN RELATED TO A RECENT INJURY THAT OCCURRED TO THE PATIENT'S HEAD, UNRELATED TO THE RNS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832396 ↗
• InjuryDec 19, 2025Positioning Problem; Positioning Problem

  FOLLOWING AN INITIAL RNS SYSTEM IMPLANT ON (B)(6) 2025, THE PATIENT REPORTED HYPERESTHESIA ON HER RIGHT FACE AND RIGHT ARM. SHE ALSO REPORTED TINGLING AND SOME NUMBNESS. THE RNS NEUROSTIMULATOR AND LEADS WERE PLACED ON THE PATIENT'S LEFT SIDE (OPPOSITE FROM AFFECTED SIDE). THE RNS SYSTEM WAS PROGRAMMED FOR DETECTION BUT NOT STIMULATION. ON (B)(6) 2025 THE PATIENT REPORTED TO THE EMERGENCY DEPARTMENT WITH CONTINUED SYMPTOMS. A CT SCAN WAS PERFORMED AT THAT TIME. BASED ON THE CT SCAN THE DOCTOR INDICATED THE PATIENT'S LEFT HIPPOCAMPAL DEPTH LEAD MAY NOT HAVE BEEN OPTIMALLY PLACED. ON (B)(6) 2025 THE PATIENT'S LEFT HIPPOCAMPAL DEPTH LEAD WAS REPLACED. THE PHYSICIAN HAS REPORTED THE PATIENT IS HEALING WELL, SHE IS STILL REPORTING SOME RIGHT SIDED SYMPTOMS, WHICH ARE BEING MONITORED BY THE PHYSICIAN.

  Patient problems: Hyperesthesia; Numbness

  MAUDE report 23857725 ↗
• InjuryJul 24, 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 PRESENTED WITH MEMORY LOSS AND DYSPHASIA. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS FOR DIAGNOSTICS AND TREATMENT. BASED ON CT AND IMAGING, THE TREATING CENTER REPORTED THIS AS AN INTRAPARENCHYMAL HEMORRHAGE WITH EDEMA. STEROIDS WERE ADMINISTERED.

  Patient problems: Dysphasia; Memory Loss/Impairment

  MAUDE report 22591914 ↗
• MalfunctionJun 16, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6) 2025, WHILE REVIEWING ECOG DATA IN PREPARATION FOR A PATIENT VISIT, SIGNAL ARTIFACT WAS OBSERVED ON THE LEFT HIPPOCAMPAL DEPTH LEAD. AT THE TIME OF IMPLANT THE LEAD WAS SECURED WITH A DOG BONE WITH LEAD PROTECTION. THE LEAD WAS PROGRAMMED 'OFF' DURING THE (B)(6) 2025 APPOINTMENT. ON (B)(6) 2025 THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216271 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2025. THE PATIENT PRESENTED TO THE ER ON DAY 6 (B)(6) 2025, POST OPERATIVELY WITH WORSENING MOTOR FUNCTION AND SPEECH DIFFICULTY, AND A PATIENT HISTORY OF SYMPTOMS HAVING STARTED ON DAY 3, POST OPERATIVELY, (B)(6) 2025 WITHOUT FEVER OR EVIDENCE OF INFECTION. CT SHOWED SEVERE EDEMA AND SOME PNEUMOCEPHALUS SURROUNDING THE IMPLANTED LEADS, THERE WAS NO EVIDENCE OF VENOUS OCCLUSION ON CTV. CONTRAST CT SHOWED POSSIBLE ABSCESS (HIGHLY UNLIKELY GIVEN TIMING FROM SURGERY). AN MRI WAS PERFORMED ON (B)(6) 2025 (FIRST POSSIBLE DAY FOR MRI) WITH NO EVIDENCE OF ABSCESS OR STROKE. THE PATIENT SHOWED IMPROVEMENT AFTER TREATMENT WITH STEROIDS ALONE. FOLLOW UP IMAGING AND INFLAMMATORY MARKERS SHOW IMPROVEMENT WITHOUT ANTIBIOTICS BEING ADMINISTERED. THE PATIENT WAS HOSPITALIZED FOR 1.5 WEEKS.

  Patient problems: Movement Disorder; Speech Disorder; Swelling/ Edema

  MAUDE report 21753061 ↗
• MalfunctionFeb 14, 2025Signal Artifact/Noise; Signal Artifact/Noise

  THE PATIENT WAS ADMITTED TO THE EMERGENCY MEDICAL UNIT ON (B)(6) 2024 AFTER REPORTING WORSENING OF SEIZURES. WHEN REVIEWING THE PATIENT ECOG DATA: SIGNAL ARTIFACT, IMPEDANCES, AND TILT ALERT WERE OBSERVED ON THE RIGHT OCCIPITAL DEPTH LEAD. TROUBLESHOOTING INCLUDED PALPATION OF THE LEAD CONNECTION, WHILE MONITORING ECOG CHANGES. THE FIRST POTENTIAL ARTIFACT SPIKING APPEARED ON (B)(6) 2024 IN A SCHEDULED ECOG ON CHANNEL FOUR (4). THE FIRST CLEAR AND OBVIOUS FLATTENING/ ARTIFACT SIGNAL WAS OBSERVED ON (B)(6) 2024. THE CAUSE WAS NOT IDENTIFIED. THE LEAD WAS SECURED WITH A DOG BONE AND LEAD PROTECTION. THE LEAD WAS REPLACED ON (B)(6) 2025.

  Patient problems: Convulsion/Seizure

  MAUDE report 21390001 ↗
• MalfunctionJan 27, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  ON (B)(6) 2024, THE DOCTOR NOTED HIGH IMPEDANCE ON THE LEFT HIPPOCAMPAL DEPTH LEAD, SUGGESTIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241581 ↗
• MalfunctionDec 2, 2024Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2024, DURING THE PATIENT'S CLINIC VISIT, A POSSIBLE LEAD BREAK WAS IDENTIFIED. THE TEAM WAS UNABLE TO PERFORM AN IMPEDANCE MEASUREMENT ON CONTACT 2 OF THE LEFT MESIAL TEMPORAL DEPTH LEAD. IMPEDANCES WERE MEASURED AND THERE WAS AN IMPEDANCE ALERT ON CONTACT 2 OF THE LEAD. A CHANGE IN PROGRAMMING WAS MADE BY TURNING OFF CONTACT 2 AND PROGRAMMED CONTACTS 1, 3, AND 4. ON (B)(6) 2024, THE LEAD WAS REPLACED AND THE EXPLANTED LEAD WILL BE RETURNED TO NEUROPACE FOR INVESTIGATION. NOTE: THE EXPLANTED LEAD WAS DAMAGED DURING THE EXPLANT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821376 ↗
• InjuryApr 11, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PRE-CLINIC REVIEW OF THE PATIENT'S ECOG IT WAS OBSERVED THAT THERE WERE SOME ECOGS THAT HAVE ARTIFACT THAT IS OFTEN ASSOCIATED WITH LEAD FRACTURES. THERE WAS AN OBSERVED CHANGE TO FLAT SIGNAL ON THE LEAD INTERSPERSED WITH HIGH AMPLITUDE ARTIFACT. PALPATION OF LEAD (RIGHT DEPTH LEAD, SECURED WITH A DOG BONE WITH LEAD PROTECTION) LEADING TO SIGNAL CHANGE ON LIVE ECOG WAS PERFORMED AND CONFIRMED THE ACTIVITY.THE PHYSICIAN REMOVED DETECTION AND STIMULATION FROM THE AFFECTED LEAD. IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE LEAD BREAK . THE LEAD WAS REPLACED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093352 ↗
• MalfunctionMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING ECOG REVIEW, IT WAS NOTED THAT THE SIGNAL LOOKED ABNORMAL. A LEAD IMPEDANCE TEST WAS RUN IN CLINIC AND SOME CONTACTS HAD HIGH IMPEDANCE VALUES. THE SURGEON BELIEVED THESE ABNORMAL VALUES WERE DUE TO A MICRO FRACTURE IN THE LEFT MESIAL TEMPORAL DEPTH LEAD. THE LEAD WAS REPLACED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000470 ↗
• MalfunctionJun 13, 2023Signal Artifact/Noise; Signal Artifact/Noise

  A FLAT LEAD SIGNAL WAS OBSERVED ON THE RIGHT MESIAL TEMPORAL LEAD, INDICATIVE OF A LEAD BREAK. A LEAD REVISION WAS PERFORMED TO REPLACE THE DAMAGED LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121229 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS TAKEN TO OR FOR PLANNED STEREO-EEG ELECTRODE REMOVAL AND PLACEMENT OF RNS WITH ACTIVE ELECTRODES OVER THE RIGHT LINGUAL GYRUS AND RIGHT LATERAL OCCIPITAL REGION. INACTIVE ELECTRODES WERE PLACED IN THE RIGHT PULVINAR NUCLEUS OF THE THALAMUS AND RIGHT MESIAL TEMPORAL AREA. A FOLLOW UP CT WAS PERFORMED ON (B)(6) 2022 AND SHOWED A 4X3 CM RIGHT FRONTAL HEMORRHAGE WITH MINIMAL MIDLINE SHIFT. THE PATIENT REPORTED NO ACUTE COMPLAINTS. MINIMAL WEAKNESS WAS OBSERVED IN THE LEFT ARM, AND THERE WAS A LEFT FACIAL DROOP ON PHYSICAL EXAM. THE PATIENT WAS MONITORED CLINICALLY AND HAD PHYSICAL THERAPY. THE SYMPTOMS IMPROVED AND SLOWLY RESOLVED AS THE HEMATOMA DECREASED IN SIZE. THE PATIENT WAS DIAGNOSED WITH AN INTRAPARENCHYMAL HEMATOMA.

  Patient problems: Facial Paralysis; Hematoma; Muscle Weakness/Atrophy

  MAUDE report 16491723 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEAD WAS EXPLANTED AFTER THE INCISION SITE SHOWED SIGNS OF EROSION. THE LEAD WAS EXPLANTED. THE TREATING SITE REPORTED A DIAGNOSIS OF EROSION AND SUPERFICIAL INCISIONAL INFECTION. THE PATIENT'S WIFE HAS REPORTED THAT THE INFECTION HAS RESOLVED. THE PATIENT IS DOING WELL.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 16141416 ↗
• 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) 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 16097395 ↗
• MalfunctionAug 22, 2022Signal Artifact/Noise; Signal Artifact/Noise

  THE TREATING CENTER IDENTIFIED UNUSUAL WAVEFORMS ON LEAD 2 DURING A PATIENT ECOG REVIEW. EVIDENCE OF A LEAD FRACTURE WAS FIRST APPARENT ON (B)(6) 2021. DURING THE NEUROPACE INVESTIGATION OF THE ECOG DATA, WE OBSERVED UNUSUAL WAVEFORMS, INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE LEAD WAS SECURED WITH A DOG BONE AND LEAD PROTECTOR. LEAD WAS IMPLANTED FOR 0.2 YEARS. THERE WAS NO IDENTIFIED CAUSE OF THE LEAD BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15270881 ↗