NeuroPace® Depth Lead Kit DL-344-10-K (UDI 00855547005014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00855547005014), received between Feb 16, 2016 and Jan 28, 2026 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Signal Artifact/Noise; High impedance

  HIGH IMPEDANCES ON THIS LEAD WERE FIRST IDENTIFIED ON 3/18/25. THE PATIENT WAS UNABLE TO ATTEND FOLLOW UP APPOINTMENTS UNTIL (B)(6) 2025. DURING THE (B)(6) 2025 VISIT, IMPEDANCES WERE CHECKED, SHOWING "INSUFFICIENT CHARGE" FOR THE FIRST THREE CONTACTS ON LEAD 1. ON (B)(6) 26, THE PATIENT HAD THE LEFT MESIAL TEMPORAL DEPTH LEAD REPLACED FOR A LEAD BREAK. THE LEAD WAS PLACED CONTRALATERAL TO THE NEUROSTIMULATOR, AND WAS SECURED WITH A DOG BONE WITH LEAD PROTECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205932 ↗
• MalfunctionNov 7, 2025Signal Artifact/Noise; Signal Artifact/Noise

  REVIEW OF THE RIGHT MESIAL TEMPORAL DEPTH LEAD ECOG EXHIBITED HIGH IMPEDANCE, SUGGESTIVE OF A POTENTIAL LEAD FRACTURE. CHANGES WERE MADE TO PROGRAMMING. ON (B)(6) 2025 THE LEAD WAS REMOVED AND A RIGHT HIPPOCAMPAL ABLATION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500499 ↗
• MalfunctionSep 11, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IN PREPARATION FOR THE PATIENT'S CLINIC FOLLOW UP VISIT, SCHEDULED FOR (B)(6) 2025, THE DAY PRIOR, A NEUROPACE EMPLOYEE UNDERTOOK A PDMS REVIEW OF PATIENT DATA AND DURING ECOG REVIEW, SIGNAL ARTIFACT AND ELEVATED IMPEDANCE WERE OBSERVED ON CONTACT 4 OF THE RIGHT HIPPOCAMPAL DEPTH LEAD. THE FOLLOWING DAY, ON (B)(6) 2025, THE CLINICAL EVALUATION REVEALED HIGH IMPEDANCE ON CONTACT 1. NO CHANGES WERE MADE TO THE STIMULATION PROGRAMMING DURING THAT VISIT. DUE TO PERSISTENT IMPEDANCE ABNORMALITIES, THE DEPTH LEAD WAS REPLACED ON (B)(6) 2025. AT THE TIME OF THE ORIGINAL IMPLANT, THE RIGHT HIPPOCAMPAL LONGITUDINAL DEPTH LEAD WAS SECURED USING A BURR HOLE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031197 ↗
• MalfunctionMay 19, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  DURING PRE-CLINIC REVIEW OF THE PATIENT'S ECOG DATA, SIGNAL ARTIFACT AND HIGHER IMPEDANCE WERE OBSERVED ON CHANNEL 4 OF THE RIGHT MESIAL TEMPORAL DEPTH LEAD SUGGESTING A LEAD FRACTURE. AT THAT TIME, THE DOCTOR DISABLED SATURATION DETECTION. THERE WAS NO INDICATED CAUSE OF THE LEAD BREAK. TRAUMA, SEIZURE, OR FALLS WERE NOT REPORTED. THE LEAD WAS REPLACED ON (B)(6) 2025. THE LEAD WAS DAMAGED DURING THE PROCESS OF THE EXPLANT. THE LEAD WAS DISCARDED BY THE NEUROSURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045284 ↗
• MalfunctionOct 5, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  DURING A ROUTINE VISIT, A REVIEW OF THE PATIENT ECOG DATA IDENTIFIED SIGNAL CHANGES, INCREASED IMPEDANCES AND SATURATIONS WHICH ARE INDICATIVE OF A LEAD BREAK. AN X-RAY SHOWED A POSSIBLE KINK UNDER THE SCALP. THE LEAD WAS REPLACED ON (B)(6) 2023. THE LEAD WAS NOT RETURNED FOR INVESTIGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882244 ↗
• MalfunctionAug 22, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2022, DURING AN ECOG REVIEW, THE PATIENT'S LEAD SHOWED EVIDENCE OF A LEAD FRACTURE. ON (B)(6) 2022 THE LEAD WAS REPLACED. THERE IS NO INFORMATION SUGGESTING THE CAUSE OF THE BREAK. THE LEAD WAS SECURED WITH DOG BONE WITH LEAD PROTECTION AND HAD BEEN IMPLANTED FOR 1.4 YEARS PRIOR TO EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271658 ↗
• MalfunctionMar 8, 2021High impedance; Impedance Problem; High impedance; Impedance Problem

  A ROUTINE DATA REVIEW OF THE PATIENT'S DATA IN PDMS INDICATED THAT THE LEAD CONNECTED TO PORT 1 DEMONSTRATED ARTIFACT AND INSUFFICIENT CHARGE DURING IMPEDANCE MEASUREMENT, SUGGESTIVE OF A LEAD BREAK. ON (B)(6) 2019, DETECTION WAS DISABLED FOR THE LEAD IN PORT 1 AND THE PATIENT CONTINUED TO RECEIVE TREATMENT VIA THE LEAD CONNECTED IN PORT 2. IN NOV 2020 IT WAS NOTED VIA A REVIEW OF THE PATIENT'S DATA IN PDMS THAT THE LEAD CONNECTED TO PORT 2 ALSO BEGAN DEMONSTRATING INTERMITTENT ARTIFACT, ALTHOUGH IMPEDANCES WERE WITHIN THE NORMAL RANGE, SUGGESTIVE OF A LEAD BREAK. ONCE THE SECOND BREAK WAS NOTED, THE PATIENT WAS SCHEDULED FOR A SURGICAL PROCEDURE TO REPLACE BOTH LEADS CONNECTED TO THE RNS NEUROSTIMULATOR. UPON EXPLANT, A BREAK WAS VISIBLY APPARENT IN BOTH LEADS, THE LEADS WERE KINKED AT THE POINT THEY WERE ANCHORED TO THE SKULL VIA A DOG-BONE PLATE (NON-NEUROPACE PRODUCT). NO COMPLICATIONS WERE REPORTED DURING THE SURGICAL PROCEDURE AND THE PATIENT IS CURRENTLY RECEIVING TREATMENT WITH THE RNS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440977 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE BEGINNING OF THE PATIENT'S INITIAL (B)(6) SYSTEM PLACEMENT, THE NEUROSURGEON INSERTED A CANNULA AS PART OF THE STANDARD NEUROSURGICAL PROCESS TO IMPLANT A NEUROPACE DEPTH LEAD. THE NEUROSURGEON NOTED BLOOD IN THE CANNULA DURING THE LEAD IMPLANTATION PROCESS AND SUBSEQUENTLY HALTED THE PROCEDURE. THE CANNULA WAS REMOVED AND THE PATIENT WAS TAKEN FOR IMAGING. PER THE NEUROSURGEON, THE CANNULA MAY HAVE PUNCTURED A BLOOD VESSEL DURING INITIAL PLACEMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED BY THE TREATING CENTER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9531847 ↗
• MalfunctionAug 23, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  IN (B)(6) 2017 A REVIEW OF THE ECOG DATA SUGGESTED A POSSIBLE LEAD BREAK ON THE RIGHT DEPTH LEAD. IN RESPONSE TO THE SIGNAL CHANGES, ADJUSTMENTS WERE MADE TO THE RESPONSIVE STIMULATION SETTINGS AT THAT TIME. THE FAMILY DID NOT REPORT ANY INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAK. THE FAMILY DECIDED TO WAIT TO REPLACE THE AFFECTED LEAD UNTIL THE PATIENT UNDERWENT A ROUTINE DEVICE REPLACEMENT; AT WHICH TIME THE AFFECTED LEAD WAS EXPLANTED AND A NEW DEPTH LEAD WAS IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925817 ↗
• MalfunctionAug 1, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  REVIEW OF THE RNS NEUROSTIMULATOR ECOG DATA INDICATED A LEAD ARTIFACT ON THE RIGHT DEPTH LEAD. THERAPY AND DETECTION WERE DISABLED ON THE AFFECTED LEAD. NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAK WERE PROVIDED BY THE TREATING CENTER. ON (B)(6) 2018 THE AFFECTED LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8853541 ↗
• MalfunctionAug 1, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  REVIEW OF THE RNS NEUROSTIMULATOR ECOGS INDICATED AN ARTIFACT ON THE LEFT DEPTH LEAD CONNECTED TO PORT 1. ON (B)(6) 2017 DURING CLINIC, THE TREATING CLINICIANS PALPATED AROUND THE GENERATOR AND THE LEAD ENTRY SITE, BUT WERE NOT ABLE TO CLEARLY INDUCE SIMILAR ARTIFACT NOTED PREVIOUSLY. THE PATIENT DOES NOT RECALL FALLING AROUND THE TIME THAT THE ARTIFACT SIGNAL WAS NOTED BUT DOES EXPERIENCE SEIZURES WHERE HE LOSES AWARENESS AND FALLS. ON (B)(6) 2018 THE AFFECTED LEAD WAS EXPLANTED AND A NEW DEPTH LEAD IMPLANTED AND CONNECTED TO PORT 1. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8852641 ↗
• InjuryAug 1, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  THE PRODUCT WAS RECEIVED AND INVESTIGATED BY NEUROPACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850710 ↗
• InjuryJul 25, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  A REVIEW OF THE PATIENT'S ECOG DATA INDICATED LOST ECOG SIGNAL AND DEMONSTRATED HIGH IMPEDANCES, SUGGESTIVE OF A POSSIBLE LEAD BREAK ON THE LEFT DEPTH LEAD. THE PATIENT REPORTED HITTING HER HEAD ON HER BED, DURING THE WINTER OF 2018 HOWEVER NO OTHER CONTRIBUTING FACTORS WERE REPORTED BY THE PATIENT OR TREATING CENTER. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2019 TO REMOVE THE LEAD AND IMPLANT A NEW LEFT DEPTH LEAD NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE AND THE SIGNALS AND IMPEDANCES FOR THE NEWLY IMPLANTED LEAD WERE WITHIN NORMAL LIMITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829472 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE TREATING CENTER REPORTED THAT THE AREA NEAR THE PATIENT'S RIGHT DEPTH LEAD INCISION SITE APPEARED TO BE INFECTED. ON (B)(6) 2019 THE DEPTH LEAD WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: Unspecified Infection

  MAUDE report 8570086 ↗
• InjuryFeb 13, 2019Break; High impedance; Break; High impedance

  A CHANGE IN THE LEFT DEPTH LEAD IMPEDANCE AND SIGNAL WAS OBSERVED IN (B)(6) 2017 DURING REMOTE REVIEW OF THE PATIENTS ECOGS AND CONFIRMED IN (B)(6) 2018 DURING A PATIENT APPOINTMENT. AT THE APPOINTMENT, THE DECISION WAS MADE TO DISABLE DETECTION ON THIS LEAD. NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER POTENTIAL CAUSAL FACTORS RESULTING IN THE LEAD BREAK WERE PROVIDED BY THE TREATING CENTER. DURING A ROUTINE BATTERY REPLACEMENT ON (B)(6) 2019, THE DEPTH LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE NEUROSTIMULATOR WITHOUT COMPLICATIONS. THE EXPLANTED LEAD WAS DAMAGED DURING THE REMOVAL PROCESS AND WAS DISCARDED BY PATHOLOGY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8335464 ↗
• InjuryDec 13, 2018Break; High impedance; Break; High impedance

  THE PATIENT HAD A DEPTH LEAD REMOVED AND REPLACED ON (B)(6) 2018. DURING A FOLLOW-UP VISIT ON (B)(6) 2018, IT WAS NOTED THAT THE LEFT DEPTH LEAD IMPEDANCES WERE HIGH. THE TREATING CLINICIAN PALPATED THE LEAD WHICH PRODUCED ARTIFACT DURING REAL-TIME ECOG RECORDINGS. A DECISION WAS MADE TO REPLACE THE LEAD WHICH DEMONSTRATED EVIDENCE OF A POSSIBLE LEAD BREAK. THE CAUSE OF THE LEAD BREAK IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160400 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWELVE DAYS AFTER RNS SYSTEM PLACEMENT, THE PATIENT PRESENTED WITH NEW ONSET DIPLOPIA, ENCEPHALOPATHY, ATAXIA, TREMOR, APRAXIA, SHORT-TERM MEMORY IMPAIRMENT, AND VISUAL HALLUCINATIONS. ANTICONVULSANT LEVELS WERE WITHIN THERAPEUTIC RANGES. INFECTIOUS AND METABOLIC WORK-UP WAS UNREMARKABLE. HEAD CT DEMONSTRATED NEW HYPODENSITIES IN THE BILATERAL OCCIPITAL LOBES CONCERNING FOR NEW EDEMA VS ARTIFACT. THE PATIENT WAS TREATED WITH HIGH-DOSE STEROIDS WITH COMPLETE RESOLUTION OF PRESENTING SYMPTOMS WITHIN ONE WEEK OF PRESENTATION.

  Patient problems: Edema

  MAUDE report 8134533 ↗
• InjuryAug 22, 2018Break; High impedance; Break; High impedance

  ON (B)(6) 2018, THE TREATING CENTER CONTACTED NEUROPACE FIELD SUPPORT PERSONNEL AFTER NOTING ARTIFACT ON THE ECOG SIGNAL FROM THE PATIENT'S RIGHT DEPTH LEAD. AFTER REVIEW BY NEUROPACE, INC., IT WAS DETERMINED THE SIGNAL ARTIFACT NOTED WAS CONSISTENT WITH THOSE SEEN WITH A POTENTIAL LEAD BREAK. THE LEAD BREAK WAS ATTRIBUTED BY THE TREATING CENTER , AS A LEAD ROUTING ISSUE, AS THE LEAD HAD ENDED UP FOLDING OVER ON ITSELF.THE LEAD WAS EXPLANTED ON (B)(6) 2018 AND A NEW LEAD WAS PLACED ON (B)(6) 2018. THE LEAD WAS DISCARDED AT THE TREATING CENTER PER THE NEUROSURGEON'S INSTRUCTIONS; AND THEREFORE WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7807981 ↗
• InjuryJun 28, 2018Break; High impedance; Break; High impedance

  IN (B)(6) 2017, HIGH IMPEDANCE WAS NOTED ON THE PORT 1 LEFT DEPTH LEAD, INDICATING A POSSIBLE LEAD BREAK. STIMULATION AND DETECTION WERE DISABLED ON THE LEAD BY THE NEUROSURGEON. THE CHANGE WAS NOT ANTICIPATED TO AFFECT PATIENT TREATMENT SINCE MOST EVENTS WERE NOTED TO OCCUR ON THE CONTRALATERAL LEAD. IN (B)(6) 2018, THE LEAD WAS REPLACED. THE LEAD WAS NOT RETURNED TO NEUROPACE BY THE TREATING CENTER SO NO ADDITIONAL INVESTIGATION COULD BE PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645804 ↗
• InjuryApr 27, 2018Signal Artifact/Noise; Break; High impedance; Signal Artifact/Noise; Break; High impedance

  THE NEUROLOGIST OBSERVED A SIGNAL ARTIFACT ON THE ECOG SIGNAL FROM THE PATIENT'S LEAD CONNECTED TO PORT 1 OF THE NEUROSTIMULATOR, INDICATING A POTENTIAL LEAD BREAK. THE ARTIFACT WAS OBSERVED/RECREATED WHILE RUNNING A REAL-TIME ECOG AND PALPATING AROUND THE REGION OF THE NEUROSTIMULATOR AND WHERE THE LEAD WAS SECURED VIA THE DOG BONE PLATE. THE PHYSICIAN THEN PROGRAMMED THE NEUROSTIMULATOR SO THE AFFECTED LEAD WAS NO LONGER PART OF THE THERAPY PATHWAY. ON (B)(6) 2018, A LEAD REVISION WAS PERFORMED. DETECTION AND THERAPY HAS BEEN RESTORED TO BOTH LEADS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7470071 ↗
• MalfunctionSep 15, 2017Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

  DURING A REVIEW OF THE PATIENT'S NEUROSTIMULATOR DATA ON (B)(6) 2016, NEUROPACE PERSONNEL NOTED THAT THERE WAS A CHANGE IN SIGNALS NOTED ON THE PATIENT'S RIGHT DEPTH LEAD INDICATIVE OF A FRACTURE. THE TREATING PHYSICIAN WAS NOTIFIED OF THIS PRIOR TO THE PATIENT'S APPOINTMENT. DURING THE PATIENT APPOINTMENT, ANOTHER IMPEDANCE MEASUREMENT WAS TAKEN WHICH DEMONSTRATED "INSUFFICIENT CHARGE" ON 3 OF THE 4 ELECTRODES. THEREFORE, THE PHYSICIAN ELECTED TO DISABLE DETECTION AND STIMULATION ON THAT LEAD AND MONITOR THE PATIENT'S RESPONSE. AS OF A YEAR LATER, THE PATIENT REPORTED NO SEIZURES AND WAS DOING WELL. AS OF (B)(6) 2017, THE NEUROPACE FIELD CLINICAL ENGINEER WAS INFORMED THAT THE LEAD HAD BEEN EXPLANTED ON (B)(6) 2016. THE EXPLANTED PRODUCT WAS RETURNED TO NEUROPACE FOR INVESTIGATION. IT WAS REPORTED THAT THE NEUROSURGEON USED A DOG BONE TO SECURE THE DEPTH LEAD AND THEN USED A WECK HEMOLOCK TO MARK THE LOCATION WHERE THE LEAD ENTERED THE BRAIN. THE INVESTIGATION WAS INCONCLUSIVE. ONLY A PARTIAL LEAD WAS RETURNED; THE DISTAL END OF THE LEAD WAS MISSING. THE LEAD APPEARED TO BE DAMAGED SIGNIFICANTLY DURING THE EXPLANT PROCESS WHICH IMPEDED IDENTIFICATION OF THE CAUSE OF THE LEAD BREAK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868528 ↗
• InjuryAug 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INITIAL IMPLANT OF THE RNS SYSTEM ON (B)(6) 2016. PATIENT WAS IMPLANTED WITH RNS NEUROSTIMULATOR AND TWO DEPTH LEADS BOTH IMPLANTED WITHIN THE RIGHT FRONTAL CORTEX. APPROXIMATELY 2 WEEKS POST OP, PATIENT DEVELOPED A NEW SEIZURE TYPE AND LEFT SIDE WEAKNESS. PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED A CT SCAN AND RESULTS REVEALED INTRA-CRANIAL SWELLING AT THE SITE OF SUPERIOR DEPTH LEAD LOCATED IN THE RIGHT FRONTAL CORTEX. INFECTION, STROKE AND MENINGITIS WERE RULED OUT BY LAB WORK-UP AND IMAGING. PATIENT WAS STARTED ON A COURSE OF IV STEROIDS IN AN EFFORT TO REDUCE SWELLING AT THE SUPERIOR DEPTH LEAD SITE. ON (B)(6) 2016 PATIENT WAS TAKEN TO THE OR FOR REMOVAL OF SUPERIOR RIGHT FRONTAL DEPTH LEAD AS SWELLING DID NOT DECREASE SIGNIFICANTLY. PATIENT'S NEUROSTIMULATOR AND INFERIOR RIGHT FRONTAL DEPTH LEAD REMAIN IMPLANTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016 AND WAS TRANSFERRED TO AN ACUTE REHAB FACILITY DUE TO LACK OF PATIENT SUPPORT AT HOME.

  Patient problems: Swelling

  MAUDE report 5884202 ↗
• MalfunctionFeb 16, 2016Break; Mechanical Problem; Break; Mechanical Problem

  DURING AN RNS SYSTEM IMPLANT PROCEDURE AND AFTER THE SURGEON PLACED THE DEPTH LEAD, THE SURGEON WENT TO REMOVE THE STYLET FROM THE DEPTH LEAD AND IT SHEARED OFF RIGHT AT THE PLASTIC CLASP. THE REMAINDER OF THE STYLET COULD NOT BE REMOVED FROM THE DEPTH LEAD AND THE SURGEON HAD TO EXPLANT THE IMPLANTED DEPTH LEAD. A REPLACEMENT LEAD WAS IMPLANTED AND THE PATIENT IS CURRENTLY IMPLANTED WITH THE RNS SYSTEM PROGRAMMED FOR DETECTION. ADDITIONAL FOLLOW UP: THE SURGEON WAS SET UP FOR DEPTH LEAD INSERTION WHEN THE STYLET BROKE SO THERE WAS NO SIGNIFICANT DELAY TO REINSERT THE NEW LEAD (THE FCE ESTIMATED 10 MINUTES). THE FCE REPORTED THE PATIENT WAS NOT AFFECTED. THE LEAD WAS REMOVED AND A NEW DEPTH LEAD WAS INSERTED DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5438324 ↗