NeuroPace® Depth Lead Kit DL-330-3.5-K (UDI 00855547005038)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00855547005038), received between Oct 17, 2018 and May 13, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  DURING REVIEW OF THE PATIENT ECOG DATA, HIGH IMPEDANCE WERE OBSERVED ON THE LEFT LEAD ((B)(6)). THIS IS INDICATIVE OF A LEAD BREAK. ARTIFACT WAS DUPLICATED WHEN THE PHYSICIAN PALPATED AROUND THE HEAD. EVIDENCE OF HIGH IMPEDANCE WAS NOTED TO HAVE STARTED AROUND(B)(6) 2023. DETECTION WAS MODIFIED. THERE IS NO REPORT OF A FALL OR TRAUMA THAT COULD HAVE CONTRIBUTED TO A LEAD BREAK. ON (B)(6) 2024 - AFTER PERFORMING AN INTERROGATION ON THE PATIENT, IMPEDANCES 2 AND 3 ON THE RIGHT LEAD (SN (B)(6)) WERE FLAT AND CONTACT 3 ON THE LEFT LEAD ((B)(6)) EXHIBITED SIMILAR BEHAVIOR. THIS SUPPORTS THE HYPOTHESIS OF A SUSPECTED LEAD FRACTURE ON BOTH LEADS, AS IMPEDANCES SHOULD BE NORMAL AND EVERY TIME THEY WERE MEASURED, THEY WERE ABNORMAL. ON (B)(6) 2024, THE PATIENT UNDERWENT LEAD EXPLANTS. BOTH THALAMIC LEADS (RIGHT AND LEFT) THAT ARE SUSPECTED TO BE FRACTURED WERE REMOVED ALONG WITH THE RNS NEUROSTIMULATOR. THE PATIENT IS SCHEDULED TO HAVE A REIMPLANT, OF THE RNS SYSTEM AFTER AN MRI IS PERFORMED TO ESTABLISH NEW THALAMIC LEAD TARGETS. THERE IS NO INDICATION OF A RNS NEUROSTIMULATOR FAILURE. REIMPLANT OF THE RNS SYSTEM IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305884 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SELF-REPORTED THAT HE WAS DIAGNOSED WITH AN INTRACRANIAL HEMORRHAGE. NEUROPACE HAS REACHED OUT TO THE EMERGENCY ROOM PHYSICIAN MULTIPLE TIMES WITH NO RESPONSE. NEUROPACE HAS REACHED OUT TO THE PATIENT'S TREATING EPILEPTOLOGIST AND IS AWAITING RESPONSE FROM THE TREATING EPILEPTOLOGIST REGARDING FURTHER DETAILS.

  Patient problems: Intracranial Hemorrhage; Muscle Weakness/Atrophy; Neuropathy

  MAUDE report 17567342 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH BILATERAL CENTROMEDIAN THALAMIC LEADS ON (B)(6) 2022. THE PATIENT PRESENTED WITH SYMPTOMS (HEADACHE, SOMNOLENCE, AND APHASIA) 10 DAYS POST-OP. THE MOTHER REPORTED THAT THE PATIENT HAS LIMITED SPEECH; PREVIOUSLY HE SPOKE IN SENTENCES. INITIAL INFORMATION PROVIDED IS THAT POST-OP CT WAS UNREMARKABLE. NO NEUROSURGICAL INTERVENTION AT THIS TIME. DIAGNOSED AS A RIGHT FRONTAL INTRAPARENCHYMAL HEMORRHAGE. THIS PATIENT HAD AN MRI ON THURSDAY, (B)(6) 2022. IT SHOWED THE BLEEDING HAD STOPPED. THE PATIENT IS STABLE. THE PATIENT REMAINS HOSPITALIZED; HE IS PENDING REHABILITATION ADMITTANCE.

  Patient problems: Headache; Hemorrhage/Blood Loss/Bleeding; Sleep Dysfunction; Speech Disorder

  MAUDE report 14397394 ↗
• MalfunctionApr 19, 2021Signal Artifact/Noise; Break; Impedance Problem; Signal Artifact/Noise; Break; Impedance Problem

  DURING A ROUTINE REVIEW OF THE PATIENT'S ECOG IN (B)(6) 2020, THE TREATING CENTER IDENTIFIED AN UNUSUAL SIGNAL ON THE DEPTH LEAD PLACED IN THE RIGHT HIPPOCAMPUS INDICATIVE OF A LEAD BREAK. STIMULATION AND DETECTION WERE DISABLED AT THAT TIME. APPROXIMATELY ONE MONTH LATER ((B)(6) 2020), THE PATIENT'S SECOND DEPTH LEAD ALSO SHOWED SIGNAL ACTIVITY SUGGESTIVE OF A LEAD BREAK. STIMULATION AND DETECTION WERE ALSO DISABLED ON THE SECOND LEAD. THE PATIENT WAS MONITORED FOR THREE MONTHS TO SEE IF THE SEIZURE FREQUENCY CHANGED AND A DECISION TO REPLACE THE LEADS WAS MADE AT THE END OF THIS PERIOD. ON (B)(6) 2021 BOTH LEADS WERE EXPLANTED AND REPLACED. NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAKS WERE PROVIDED BY THE TREATING CENTER. THE NEWLY IMPLANTED LEADS ARE FUNCTIONING AS INTENDED AND RESPONSIVE STIMULATION WAS ENABLED AT THE TIME OF THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686550 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROPACE WAS NOTIFIED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE AND SUBSEQUENTLY HAD BOTH DEPTH LEADS EXPLANTED ON (B)(6) 2019. THE SURGICAL SITE WAS WASHED-OUT WITH AN ANTIBIOTIC SOLUTION AFTER THE LEADS WERE REMOVED. CULTURES FROM THE PROCEDURE ARE PENDING.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 8551031 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH TWO RNS SYSTEM DEPTH LEADS ON (B)(6) 2018. POST-LEAD PLACEMENT MRI REVEALED AN INTRAVENTRICULAR HEMORRHAGE IN THE LEFT LATERAL VENTRICLE FROM THE LEFT THALAMIC LEAD PLACEMENT. FINAL INTRA-OP MRI SEQUENCES REVEALED STABILITY OF THE HEMORRHAGE. AS A SAFETY PRECAUTION, THE NEUROSURGEON POSTPONED THE NEUROSTIMULATOR PLACEMENT PROCEDURE.

  Patient problems: Hemorrhage, Intraventricular

  MAUDE report 7974299 ↗