NeuroPace® Depth Lead Kit DL-344-3.5-K (UDI 00855547005021)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00855547005021), received between Jan 26, 2017 and May 21, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (6 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.

• MalfunctionMay 21, 2026High impedance

  REVIEW OF THE PATIENT ECOG DATA SHOWED HIGH IMPEDANCE ON THE LEFT THALAMUS (CM) DEPTH LEAD (SECURED WITH A BURR HOLE), INDICATING A LEAD BREAK. IT APPEARS THE LEAD WAS DAMAGED DURING THE (B)(6) 2024 ROUTINE REPLACEMENT. THE LEAD WAS REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249710 ↗
• MalfunctionJul 14, 2025Signal Artifact/Noise; Signal Artifact/Noise

  LEFT THALAMUS (CM) DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION SHOWS ARTIFACT ON THE ECOG SIGNAL, INDICATIVE OF A LEAD BREAK. THE LEAD WAS REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495854 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION: ON (B)(6) 2025 THE PATIENT RETURNED TO THE OPERATING ROOM (B)(6) TO ADDRESS THE WOUND AT THE LEFT POSTERIOR ENTRY SITE FOR A 10 MM HIPPOCAMPAL DEPTH LEAD. TREATMENT INCLUDED A WOUND WASH OUT, EXPLANT OF THE BURR HOLE COVER AND REMAINING PORTION OF THE DEPTH LEAD. PLASTIC SURGICAL CONSULT ASSISTED WITH CLOSURE. THE PATIENT REPORTEDLY HAS BEEN 'PICKING' AT THE WOUND, WHICH RESULTED IN THE CONTINUATION OF THE WOUND HEALING CONCERNS. THERE WAS NO EVIDENCE OF INFECTION. BASED ON THIS NEW INFORMATION IT IS BELIEVED THAT SN (B)(6) WAS NOT THE LEAD THAT WAS EXPLANTED IN (B)(6) 2025. IT IS BELIEVED THAT SN (B)(6) WAS PARTIALLY EXPLANTED IN (B)(6) 2025. ORIGINAL REPORT. THE PATIENT'S LEFT POSTERIOR DEPTH LEAD ERODED THROUGH HER SCALP WHILE TRAVELING IN (B)(6) AREA. THE PATIENT'S COLUMBIA TEAM RECOMMENDED SHE GO TO THE ER, WHERE SHE WAS SEEN UNDER THE CARE OF DR. (B)(6). THE EXPLANTED DEPTH LEAD WAS NOT CONNECTED TO THE RNS NEUROSTIMULATOR. UNSPECIFIED ORAL ANTIBIOTICS WERE ADMINISTERED.

  Patient problems: Erosion; Impaired Healing; Twiddlers Syndrome

  MAUDE report 22180953 ↗
• MalfunctionNov 6, 2024Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  ON (B)(6) 2024, THE EPILEPTOLOGIST FIRST IDENTIFIED SIGNAL ARTIFACT AND HIGH IMPEDANCE ON THE LEFT INSULA DEPTH LEAD. AT THAT TIME, LEAD DETECTION WAS MODIFIED ON THE LEAD. THERE IS NO INDICATION AS TO THE CAUSE OF THE PROBABLE LEAD BREAK. ON (B)(6) 2024, THE PATIENT UNDERWENT REPLACEMENT OF THE LEAD. DURING THE REPLACEMENT PROCEDURE, THE CONNECTOR COVER WAS INSPECTED, CLEANED OUT AND RE-TESTED. UPON EVALUATION OF THE LEAD AT THE ENTRY POINT INTO THE SKULL, IT WAS NOTED THAT THE LEAD HAD A SHARP BEND WHEN EXITING THE DOG-BONE PLATE, WHICH COULD HAVE BEEN WHERE A FRACTURE OCCURRED. NEUROPACE IS PENDING INFORMATION WHICH WOULD INDICATE IF THE LEAD WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622152 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN INITIAL IMPLANT OF THE RNS SYSTEM AND TWO DEPTH LEADS ON (B)(6) 2021. ON THE EVENING OF (B)(6) 2021, THE PATIENT UNDERWENT AN EVACUATION OF AN INTRAPARENCHYMAL AND SUBDURAL HEMATOMA ADJACENT TO THE NEUROSTIMULATOR AND THE RIGHT DEPTH LEAD AND A PREVIOUSLY IMPLANTED SHUNT. THE LEAD WAS EXPLANTED AND A PLUG WAS PLACED IN THAT PORT OF THE NEUROSTIMULATOR. THE PATIENT HAD PREVIOUSLY EXPERIENCED A TRAUMATIC BRAIN INJURY IN THE REGION WHERE THE HEMORRHAGE OCCURRED THAT REQUIRED MULTIPLE INTRACRANIAL PROCEDURES AND PLACEMENT OF THE SHUNT. THE SURGEON FELT THAT THE IMPLANTATION OF THE LEAD MOST LIKELY CONTRIBUTED TO THE HEMORRHAGE.

  Patient problems: Hematoma

  MAUDE report 12908961 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2021: THE PATIENT PRESENTED WITH SCAB LIKE HEALING AROUND THE INCISION SITE INCLUDING INCISION DRAINAGE. THIS WAS REPORTED AS AN ON-GOING INFECTION REPORTED TO BE SUPERFICIAL AND IN THE TISSUE AROUND THE LEADS THE PATIENT WAS SENT TO POST-ANESTHESIA CARE UNIT (PACU) FOR A VACUUM-ASSISTED WOUND CLOSURE. DIAGNOSED AS A SUPERFICIAL AND DEEP INCISIONAL INFECTION

  Patient problems: Bacterial Infection

  MAUDE report 12483360 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROPACE WAS INFORMED ON (B)(6) 2019 THAT THE RIGHT DEPTH LEAD WAS VISIBLE THROUGH THE SCALP. ON (B)(6) 2019, THE LEAD WAS EXPLANTED AND A PREVIOUSLY IMPLANTED LEAD WAS CONNECTED TO THE RNS NEUROSTIMULATOR. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: Erosion

  MAUDE report 9240325 ↗
• InjuryAug 15, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  NEUROPACE BECAME AWARE OF A POSSIBLE LEAD BREAK BASED ON REVIEW OF THE PATIENT'S ECOG DATA IN (B)(6) 2019 AND THE TREATING CENTER WAS NOTIFIED. THE RNS SYSTEM REMAINED IMPLANTED WITH STIMULATION AND DETECTION ENABLED. THE CENTER PERFORMED CONFIRMATORY TESTING IN CLINIC; HOWEVER THE TESTING WAS LIMITED DUE TO THE CLEAR SIGNAL CHANGE AND ABNORMAL IMPEDANCE MEASUREMENTS. THE RIGHT DEPTH LEAD WAS SUBSEQUENTLY EXPLANTED AND A NEW LEAD IMPLANTED ON (B)(6) 2019 DURING A ROUTINE NEUROSTIMULATOR REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898197 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PLANNED STAGED RNS SYSTEM IMPLANT PROCEDURE, WITH THE RNS SYSTEM LEADS PLACED DURING THE INITIAL PROCEDURE ON (B)(6) 2019. THE RNS NEUROSTIMULATOR WAS NOT IMPLANTED AT THAT TIME, WITH PLACEMENT PLANNED FOR A FUTURE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE LEAD PLACEMENT. ON (B)(6) 2019 THE TREATING CENTER REPORTED THAT THE PATIENT HAD DECREASED COORDINATION OF THE LEFT HAND. THE PATIENT WAS DIAGNOSED WITH CEREBRAL EDEMA ATTRIBUTED TO THE SURGICAL PROCEDURE ASSOCIATED WITH THE IMPLANT OF THE TWO LEADS. THE TREATING CENTER NOTED THAT THIS WAS AN ANTICIPATED EVENT. TREATMENT INCLUDED DEXAMETHASONE AND ONE NIGHT OF HOSPITALIZATION FOR OBSERVATION.

  Patient problems: Edema; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8621999 ↗
• InjuryApr 9, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  A REVIEW OF THE PATIENT'S ECOG DATA INDICATED SIGNAL ARTIFACT ON THE LEFT DEPTH LEAD (PORT 1) STARTING ON (B)(6) 2018, SUGGESTIVE OF A POSSIBLE LEAD BREAK. THE PATIENT WAS SCHEDULED FOR A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT AND REPLACEMENT OF THE LEAD IN (B)(6) 2019. SUBSEQUENTLY, THE PATIENT'S RIGHT DEPTH LEAD CONNECTED TO PORT 2, DEMONSTRATED SIMILAR ISSUES STARTING ON (B)(6) 2019 . NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAKS WERE PROVIDED BY THE TREATING CENTER. DURING THE SURGICAL PROCEDURE ON (B)(6) 2019, BOTH LEADS WERE REMOVED AND TWO NEW DEPTH LEADS WERE IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498193 ↗
• InjuryApr 9, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  A REVIEW OF THE PATIENT'S ECOG DATA INDICATED SIGNAL ARTIFACT ON THE LEFT DEPTH LEAD (PORT 1) STARTING ON (B)(6) 2018, SUGGESTIVE OF A POSSIBLE LEAD BREAK. THE PATIENT WAS SCHEDULED FOR A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT AND REPLACEMENT OF THE LEAD IN (B)(6) 2019. SUBSEQUENTLY, THE PATIENT'S RIGHT DEPTH LEAD CONNECTED TO PORT 2, DEMONSTRATED SIMILAR ISSUES STARTING ON (B)(6) 2019 . NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAKS WERE PROVIDED BY THE TREATING CENTER. DURING THE SURGICAL PROCEDURE ON (B)(6) 2019, BOTH LEADS WERE REMOVED AND TWO NEW DEPTH LEADS WERE IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498192 ↗
• InjuryJan 26, 2017Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

  ON (B)(6) 2016 THE PATIENT ECOGS WERE REVIEWED AND SQUARE SIGNALS WERE OBSERVED ON CHANNELS 1 AND 2 (SN (B)(4)) ADDITIONAL TESTING OF THE LEAD IMPEDANCES REVEALED INSUFFICIENT CHARGE AND IRREGULARITY IN THE LEAD SIGNAL. BASED ON TROUBLESHOOTING IT WAS BELIEVED THAT THE IRREGULAR SIGNAL WAS A RESULT OF A LEAD BREAK. THERE WAS NO INDICATION OF SIGNAL ISSUE WITH THE RIGHT LEAD AT THAT TIME. THE LEFT LEAD DETECTION AND THERAPY WERE DISABLED. ON (B)(6) 2016 THE PATIENT RETURNED FOR FOLLOW UP. IT WAS NOTED THAT THE LEFT DEPTH LEAD ISSUES CONTINUED AND IMPEDANCES/ECOG SIGNALS WERE ABNORMAL. IT WAS BROUGHT TO DR. (B)(6) ATTENTION THAT ON (B)(6) 2016 THERE WAS ARTIFACT SEEN ON THE RIGHT DEPTH LEAD (SN (B)(4)) AS WELL AND IMPEDANCE CHECKS REVEALED THAT THERE WAS 'INSUFFICIENT CHARGE' ON CONTACT RHIP4. DR. (B)(6) COUNSELED THE PATIENT ON REPLACING BOTH LEADS AS SHE FELT THE TROUBLESHOOTING INDICATED BOTH LEADS WERE POSSIBLY FRACTURED. ON (B)(6) 2016- DURING THE SURGICAL CASE, AFTER EXPOSING THE DEVICE, THE LEFT AND RIGHT DEPTH LEADS WERE REMOVED FROM THEIR ORIGINAL PORTS AND PLACED IN THE OPPOSITE PORTS. (LEFT DEPTH=PORT2 / RIGHT DEPTH=PORT1) IMPEDANCES AND ECOG SIGNALS WERE THEN CHECKED AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6279244 ↗