NeuroPace® Depth Lead Kit DL-344-10-K (UDI 00855547005298)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00855547005298), received between Jul 22, 2022 and Jul 14, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (18 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813526 ↗
• MalfunctionJun 5, 2026Signal Artifact/Noise; High impedance

  ON (B)(6) 2025, EVIDENCE WAS NOTED OF SIGNAL ARTIFACT AND HIGH IMPEDANCE ON THE RIGHT MESIAL TEMPORAL DEPTH LEAD, LONGITUDINAL, SECURED WITH DOG BONE WITH LEAD PROTECTION. THIS LEAD WAS CONNECTED TO AN RNS WHICH WAS IMPLANTED IN THE AREA OF THE BACK OF THE PATIENT. SIGNAL ARTIFACT AND HIGH IMPEDANCE IS INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED ON (B)(6) 26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417454 ↗
• InjuryJun 5, 2026Signal Artifact/Noise; High impedance

  ON (B)(6) 2025 EVIDENCE WAS NOTED OF SIGNAL ARTIFACT ON THE LEFT MESIAL TEMPORAL DEPTH LEAD, LONGITUDINAL, SECURED WITH DOG BONE WITH LEAD PROTECTION. SIGNAL ARTIFACT IS INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417418 ↗
• MalfunctionApr 15, 2026High impedance

  ON (B)(6) 2026, THERE WAS EVIDENCE OF A LEAD BREAK ON THE LEFT MESIAL TEMPORAL DEPTH LEAD CONTRALATERAL TO THE RNS DOG BONE WITH LEAD PROTECTION. ECOG REVIEW IDENTIFIED FLAT SIGNAL AND A TILT ALERT. THE UNUSUAL SIGNAL COINCIDES WITH THE DATE THAT THE PATIENT FELL IN THE SHOWER. ON (B)(6) 2026, THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886810 ↗
• MalfunctionMar 17, 2026Signal Artifact/Noise

  1. ON (B)(6) 2026 NPCE IDENTIFIED EVIDENCE OF A LEAD BREAK. SIGNAL ARTIFACT AND HIGH IMPEDANCE WERE NOTED ON THE ON THE LEFT PARIETAL DEPTH LEAD SECURED WITH A DOG BONE WITH LEAD PROTECTION. THE LEAD IS CONTRALATERAL TO THE RNS DEVICE. 2. THE LEAD PROGRAMMING WAS TURNED OFF. THE PATIENT REPORTED THAT SHE HIT HER HEAD HARD WHEN EXITING HER CAR, WHICH MAY HAVE CONTRIBUTED TO THE LEAD BREAK 3. THE LEAD WAS REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621609 ↗
• MalfunctionJan 28, 2026High impedance

  IN (B)(6) 2025, A HIGH IMPEDANCE ISSUE WAS IDENTIFIED ON THE RIGHT HIPPOCAMPAL DEPTH LEAD CONTRALATERAL TO THE RNS, SECURED WITH A BURR HOLE COVER. INITIALLY, STIMULATION AND DETECTION WERE REMOVED FROM THAT LEAD BUT THE LEAD CONTINUED TO SHOW HIGH IMPEDANCE AND WAS ULTIMATELY REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205931 ↗
• MalfunctionDec 16, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  ON (B)(6) 2025, DURING A ROUTINE REVIEW OF PATIENT ECOG DATA, UNUSUAL ELECTROGRAPHIC SIGNAL COUPLED WITH UNMEASURED/HIGH IMPEDANCES AND A TILT ALERT WERE OBSERVED. THESE ARE INDICATIVE OF A LEAD BREAK OF THE LEFT MESIAL TEMPORAL DEPTH LEAD, SECURED WITH DOG BONE WITH LEAD PROTECTION. FIRST EVIDENCE OF A BREAK WAS OBSERVED ON THE (B)(6) 2025 ECOG. ON (B)(6) 2025, THE LEFT LEAD WAS TURNED "OFF". ON (B)(6) 2025, THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817406 ↗
• InjuryDec 3, 2025Positioning Problem; Positioning Problem

  THE PATIENT UNDERWENT INITIAL IMPLANTATION OF THE RNS SYSTEM ON (B)(6) 2025. POST OPERATIVELY, THE PATIENT EXPERIENCED AN INTRAPARENCHYMAL HEMORRHAGE AT THE ENTRY SITE OF THE RIGHT HIPPOCAMPAL DEPTH LEAD. THE PATIENT REPORTED PERIPHERAL VISION LOSS ON THE CORRESPONDING SIDE. NO SURGICAL INTERVENTION WAS PERFORMED; HOWEVER, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. TREATMENT INCLUDED ADMINISTRATION OF NAYZILAM FOR FOCAL IMPAIRED SEIZURES ON THE DAY OF THE HEMORRHAGE ((B)(6)), ALONG WITH CORTICOSTEROIDS. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS. THE HEMORRHAGE IS SUSPECTED TO BE ASSOCIATED WITH A DEVIATION FROM THE PLANNED TRAJECTORY, POTENTIALLY DUE TO INACCURACY OF THE NEUROMATE ROBOTIC SYSTEM .

  Patient problems: Intracranial Hemorrhage; Visual Impairment

  MAUDE report 23709291 ↗
• MalfunctionDec 2, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PATIENT ECOG REVIEW ON (B)(6) 2025, SIGNAL ARTIFACT WAS OBSERVED ON THE LEFT HIPPOCAMPAL DEPTH LEAD, INDICATIVE OF A LEAD BREAK. THE LEAD WAS REPLACED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694411 ↗
• MalfunctionAug 29, 2025Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  ON (B)(6) 2025 EVIDENCE OF A SUSPECTED LEAD BREAK WAS OBSERVED ON THE PATIENT'S ECOG. THE ECOG DATA DISPLAYED LOW IMPEDANCE AND SIGNAL ARTIFACT ON CHANNEL 1 OF THE LEFT MESIAL TEMPORAL HIPPOCAMPAL DEPTH LEAD (SECURED WITH DOG BONE WITH LEAD PROTECTION). ON (B)(6) 2025 THE PATIENT UNDERWENT A LEAD REVISION. THE LEAD WAS RETURNED TO NPCE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927030 ↗
• MalfunctionJun 10, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6) 2025, THE LEFT MESIAL TEMPORAL LEAD WAS DETERMINED TO HAVE A PROBABLE LEAD BREAK BASED ON ECOG REVIEW. THE LEAD IS SECURED WITH A DOG BONE WITH LEAD PROTECTION. THE LEAD IS ATTACHED TO THE RNS NEUROSTIMULATOR PLACED UNDER THE RIGHT SHOULDER. ON (B)(6) 2025, THE LEAD WAS EXPLANTED. THE SURGEON IMPLANTED A SECOND RNS NEUROSTIMULATOR UNDER THE LEFT SHOULDER AND PLACED TWO NEW DEPTH LEADS IN THE PATIENT'S LEFT HEMISPHERE. THE SURGEON ALSO ADDED AN ADDITIONAL DEPTH LEAD TO THE RIGHT NEUROSTIMULATOR WHICH WAS PLACED IN THE RIGHT HEMISPHERE. UPON EXPLANT THE LEAD BREAK WAS OBSERVED TO HAVE A CLEAN BREAK OF THE COILS WITHIN THE LEAD CASING ALONG THE BODY OF THE LEAD. THE BREAK WAS NOT NEAR A POINT OF FIXATION. THE LEAD WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180954 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANTATION THE PATIENT EXPERIENCED A SUBDURAL HEMORRHAGE WHEN THE RIGHT MESIAL TEMPORAL DEPTH LEAD WAS BEING POSITIONED. THE PROCEDURE WAS DISCONTINUED. THE LEAD REMAINS IMPLANTED, CAPPED AND SECURED WITH A DOG BONE FOR LEAD PROTECTION. BLEEDING HAS RESOLVED WITH NO ADDITIONAL INTERVENTION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22045283 ↗
• MalfunctionApr 17, 2025Signal Artifact/Noise; High impedance; Impedance Problem; Signal Artifact/Noise; High impedance; Impedance Problem

  THE CLINICIAN HAS BEEN MANAGING LEAD SIGNALS WHERE HIGH IMPEDANCE AND SIGNAL ARTIFACT HAVE BEEN OBSERVED AND RECORDED ON THE PATIENT ECOG DATA AS EARLY AS (B)(6) 2023. PALPATING THE SCALP ABOVE THE LEAD REPRODUCED SIGNAL ARTIFACT. ON (B)(6) 2024, A PROGRAMMING CHANGE WAS MADE TO THE LEAD. ON (B)(6) 2024, THE LEAD BREAK WAS CONFIRMED BY X-RAY. ON (B)(6) 2025, THE LEAD WAS REPLACED. IT IS BELIEVED THAT IMPROPER ANCHORING OF THE LEAD AT THE SKULL CONTRIBUTED TO THE LEAD BREAK. DURING THE EXPLANT IT WAS OBSERVED THAT THE LEAD APPEARED TO BE PINCHED AT THE POINT OF FIXATION. THE LEFT MESIAL TEMPORAL DEPTH LEAD WAS SECURED WITH A DOG BONE WITH LEAD PROTECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860202 ↗
• MalfunctionJan 27, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IN (B)(6) 2024, DURING A CLINIC APPOINTMENT THE PATIENT'S ECOG DATA WAS REVIEWED. THE DOCTOR NOTED INSUFFICIENT CHARGE AND ARTIFACT ON THE RIGHT MESIAL TEMPORAL DEPTH LEAD. EVIDENCE OF A LEAD BREAK WAS OBSERVED AS EARLY AS (B)(6) 2024. THERE WAS NO CHANGE IN PROGRAMMING DURING THE (B)(6) 2024 APPOINTMENT. THE PATIENT UNDERWENT A LEAD REPLACEMENT ON (B)(6) 2024 FOR A PROBABLE LEAD BREAK. THE POSSIBLE CAUSE WAS POSSIBLY RELATED TO THE PATIENT HITTING HER HEAD, VERY HARD, ON THE RIGHT SIDE OF HER HEAD ON AN UNDETERMINED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241914 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROPACE RECEIVED A PATIENT UPDATE ON (B)(6) 2025. THE PATIENT WAS PREVIOUSLY TREATED FOR EROSION AND LEAD PROTRUSION. NEW INFORMATION REPORTED THE PATIENT WAS PRESCRIBED KEFLEX AFTER DEVELOPING A NEW WOUND BREAKDOWN AT THE PREVIOUSLY TREATED INCISION SITE. THE DATE OF THIS TREATMENT WAS NOT PROVIDED. THE SURGEON PRESCRIBED ANTIBIOTICS TWO MORE TIMES BEFORE EXPLANTING THE RNS SYSTEM. ON (B)(6) 2025, THE SURGEON EXPLANTED THE RNS SYSTEM (NEUROSTIMULATOR AND TWO DEPTH LEADS). EVENT WAS ORIGINALLY REPORTED ON (B)(6) 2025. ON (B)(6) 2024 THE PATIENT PRESENTED WITH EROSION AT THE INCISION SITE. THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL INCISIONAL EROSION AND A WOUND WASHOUT WAS PERFORMED. ON (B)(6), 2024, A SECOND WOUND REVISION WAS PERFORMED TO TREAT EROSION AT THE INCISION SITE INCLUSIVE OF A LEAD PROTRUSION. TREATMENT ALSO INCLUDED ANTIBIOTIC THERAPY; INTRAOPERATIVE VANCOMYCIN POWDER AND INTRAVENOUS ANCEF (CEFAZOLIN) (AT THE TIME OF SURGERY). AT THAT TIME, THE RNS NEUROSTIMULATOR AND TWO DEPTH LEADS REMAINED IMPLANTED AND THE DEVICE WAS PROGRAMMED FOR THERAPY.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 21023394 ↗
• 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 20821344 ↗
• MalfunctionJul 15, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ON 3/8/24 THE PATIENT SUFFERED A GRAND MAL EVENT IN WHICH HE WAS FOUND UNRESPONSIVE AND SENT VIA MED FLIGHT TO DARTMOUTH. THE PHYSICIAN DETERMINED THAT THE LEADS WERE MOST LIKELY BROKEN. REVIEW OF THE ECOG DATA FOR BOTH LEADS IDENTIFIED THE IMPEDANCES TO BE HIGH AND OUT OF RANGE. THE PHYSICIAN REPROGRAMMED THE DEVICE IN MAY WITH NO POSITIVE RESULTS. IT IS BELIEVED THAT WHEN THE PATIENT FELL THE LEADS WERE DAMAGED. THE PATIENT UNDERWENT A LEAD REVISION ON (B)(6) 2024. DURING THE REVISION PROCESS - THE SURGEON FIRST REPLACED THE BATTERY, THE IMPEDANCES REMAINED THE SAME. HE THEN EXPLANTED BOTH DEPTH LEADS, AND THEN RE-IMPLANTED NEW DEPTH LEADS IMMEDIATELY. THE IMPEDANCES WERE WELL WITHIN RANGE AT THIS TIME. DETECTION AND STIMULATION HAVE BEEN RE-ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742470 ↗
• MalfunctionJul 15, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  ON (B)(6) 2024 THE PATIENT SUFFERED A GRAND MAL EVENT IN WHICH HE WAS FOUND UNRESPONSIVE AND SENT VIA MED FLIGHT TO DARTMOUTH. THE PHYSICIAN DETERMINED THAT THE LEADS WERE MOST LIKELY BROKEN. REVIEW OF THE ECOG DATA FOR BOTH LEADS IDENTIFIED THE IMPEDANCES TO BE HIGH AND OUT OF RANGE. THE PHYSICIAN REPROGRAMMED THE DEVICE IN MAY WITH NO POSITIVE RESULTS. IT IS BELIEVED THAT WHEN THE PATIENT FELL THE LEADS WERE DAMAGED. THE PATIENT UNDERWENT A LEAD REVISION ON (B)(6)2 024. DURING THE REVISION PROCESS - THE SURGEON FIRST REPLACED THE BATTERY, THE IMPEDANCES REMAINED THE SAME. HE THEN EXPLANTED BOTH DEPTH LEADS, AND THEN RE-IMPLANTED NEW DEPTH LEADS IMMEDIATELY. THE IMPEDANCES WERE WELL WITHIN RANGE AT THIS TIME. DETECTION AND STIMULATION HAVE BEEN RE-ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742431 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ONSET DATE WAS REPORTED AS 2/18/24. THE CENTER REPORTED A LEAD SITE INFECTION. THE RNS SYSTEM (NEUROSTIMULATOR AND TWO LEADS) WERE EXPLANTED ON (B)(6) 2024. TREATMENT INCLUDED IV ANTIBIOTICS (DAPTOMYCIN AND ROCEPHIN) FOR APPROXIMATELY 6 WEEKS. THE INFECTION RESOLVED WITH TREATMENT. DIAGNOSED AS AN INTRAPARENCHYMAL INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 18896074 ↗
• MalfunctionOct 27, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2023, DURING PATIENT ECOG REVIEW, AN UNUSUAL SIGNAL WAS OBSERVED ON THE LEFT DEPTH LEAD (IMPLANTED (B)(6) 2022). DURING THE LEAD REVISION PROCEDURE, IT WAS OBSERVED THE LEAD HAD A PHYSICAL BREAK NEAR THE BURR HOLE COVER. UNFORTUNATELY, THE SURGEON CUT THE LEAD AT THE EXACT SPOT OF THE FRACTURE. THERE IS NO INDICATION OF THE CAUSE OF THE LEAD BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022690 ↗
• MalfunctionJun 7, 2023Signal Artifact/Noise; Signal Artifact/Noise

  A FLAT LEAD SIGNAL WAS OBSERVED ON THE LEFT HIPPOCAMPAL LEAD, INDICATIVE OF A LEAD BREAK. A LEAD REVISION WAS PERFORMED TO REPLACE THE DAMAGED LEAD. IT APPEARS THE SURGEON SECURED THE LEAD WITH TWO DOG BONES AT THE INITIAL IMPLANT WHICH MAY HAVE CONTRIBUTED TO THE OBSERVED 'KINK' IN THE LEAD. THE LEAD WAS DAMAGED DURING THE REPLACEMENT PROCESS AND WAS NOT RETURNED FOR INVESTIGATION. A NEW LEAD WAS SUCCESSFULLY IMPLANTED, REPLACING THE DAMAGED LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080290 ↗
• MalfunctionJan 11, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  THE PATIENT'S RIGHT DEPTH LEAD DISPLAYED ABNORMAL SIGNALS, SATURATION, AND FLAT LINE ACTIVITY DURING REVIEW OF PATIENT ECOG DATA. THE ABNORMAL ACTIVITY APPEARS TO HAVE BEGUN AROUND (B)(6) 2022. THESE ACTIVITIES ARE INDICATIVE OF A RIGHT DEPTH LEAD BREAK. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. DURING EXPLANT THE SURGEON REPORTED EVIDENCE OF LEAD DAMAGE NEAR THE BURR HOLE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138373 ↗
• MalfunctionDec 7, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  IN JAN 2021 THE PATIENT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND THREE LEADS (TWO DEPTH LEADS IN THE RIGHT HEMISPHERE AND ONE STRIP LEAD IN THE LEFT HEMISPHERE. ONE DEPTH LEAD AND ONE STRIP LEAD WERE CONNECTED TO THE RNS NEUROSTIMULATOR DURING THE PROCEDURE). IN JUN 2022 THERE WAS UNUSUAL SIGNAL OBSERVED ON THE RIGHT DEPTH LEAD DURING ECOG REVIEW. AT THAT TIME THE DOCTOR FELT THAT THERE WAS SUFFICIENT LEAD ACTIVITY AND NO CHANGES WERE MADE. IN JULY 2022, THE SIGNAL ARTIFACT WAS DETERMINED TO BE ON THE THIRD CONTACT OF THE RIGHT DEPTH LEAD. DURING THE JUL 2022 CLINICAL VISIT THE LEAD IN QUESTION WAS PROGRAMMED TO DISCONTINUE STIMULATION BUT DETECTION WAS LEFT ACTIVE. THE PATIENT DOES EXPERIENCE FALL SEIZURES, WHICH MAY BE THE CAUSE OF THE LEAD BREAK. ON (B)(6) 2022 THE PATIENT UNDERWENT A LEAD REVISION. THE LEAD IN QUESTION WAS DISCONNECTED FROM THE NEUROSTIMULATOR AND THE OTHER (PREVIOUSLY IMPLANTED) DEPTH LEAD WAS CONNECTED. THE LEAD IN QUESTION REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934169 ↗
• MalfunctionSep 8, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2022 THE TREATING CENTER REPORTED THE PATIENT HAD A SUSPECTED LEAD FRACTURE. THEY OBSERVED A DISTINCT INCREASE IN THE LEAD IMPEDANCE, ARTIFACT AND SATURATION. THE LEAD WAS REPLACED DURING A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT DUE TO EXPECTED LOW BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383446 ↗
• MalfunctionJul 26, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  DURING PATIENT ECOG REVIEW ON (B)(6) 2022, THE DOCTOR OBSERVED AN IMPEDANCE ALERT ON ONE OF THE DEPTH LEADS, INDICATING INSUFFICIENT CHARGE AND A POSSIBLE LEAD BREAK. TROUBLESHOOTING INCLUDED; REPEATED IMPEDANCE CHECKS, PALPATION OF THE LEAD ENTRY. STIMULATION WAS DISABLED TO THAT LEAD. THERE IS NO INFORMATION SUGGESTING THE CAUSE OF THE BREAK. THE LEAD WAS EXPLANTED ON (B)(6) 2022 AND RETURNED TO NEUROPACE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107140 ↗