NeuroPace® Depth Lead Kit DL-330-10-K (UDI 00855547005045)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00855547005045), received between Sep 2, 2015 and Mar 16, 2026 — classified as 16 injuries, 14 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Signal Artifact/Noise

  EVIDENCE OF A LEAD BREAK ON THE LEFT TEMPORAL (NON-MESIAL) DEPTH LEAD WITH NO FIXATION WAS NOTED, DURING AN ECOG REVIEW. THE ECOG DATA SHOWED FIRST EVIDENCE OF A LEAD BREAK ON (B)(6) 2025. THE LEAD SIGNAL APPEARED FLAT WITH OCCASIONAL ARTIFACT AS WELL AS SOME LONG EPISODE ECOGS. ON (B)(6) 2026, THE LEAD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610758 ↗
• MalfunctionNov 7, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6) 2025, THE RIGHT MESIAL TEMPORAL DEPTH LEAD EXHIBITED ECOG ARTIFACT AND ELEVATED SATURATION LEVELS, FINDINGS SUGGESTIVE OF A POTENTIAL LEAD FRACTURE. AS A RESULT, PROGRAMMING ADJUSTMENTS WERE IMPLEMENTED. ON (B)(6) 2025 THE LEAD WAS REPLACED. THE LEAD WAS SECURED WITH A BURR HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500520 ↗
• MalfunctionMar 28, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  DURING A ROUTINE REVIEW OF THE PATIENT ECOG DATA, HIGH IMPEDANCES AND SIGNAL ARTIFACT WERE OBSERVED ON LEAD 1. THESE UNUSUAL SIGNALS WERE INDICATIVE OF A LEAD BREAK. ON (B)(6) 2023, THE TREATING PHYSICIAN TURNED OFF DETECTION AND STIMULATION FOR THAT LEAD. ON (B)(6) 2023, THE PATIENT UNDERWENT A SYSTEM EXPLANT (THE NEUROSTIMULATOR AND FOUR LEADS, INCLUDING THE SUSPECT LEAD). ON (B)(6) 2023, THE PATIENT WAS REIMPLANTED WITH THE RNS AND FOUR LEADS. THE RNS SYSTEM WAS EXPLANTED AND REPLACED TO REPOSITION THE LEADS AND IMPROVE EFFECTIVITY OF THE RNS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628740 ↗
• MalfunctionOct 1, 2022Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  ON (B)(6) 2022, A NEUROPACE DEPTH LEAD WAS OBSERVED TO HAVE INSUFFICIENT CHARGE ON ALL ELECTRODE CONTACTS(4), SIGNAL ARTIFACT, AND ABNORMAL IMPEDANCES, INDICATIVE OF A LEAD BREAK. THIS WAS CONFIRMED BY NEUROPACE AFTER REVIEW OF THE INTRACRANIAL EEG RECORDINGS FROM THAT LEAD. NEUROPACE CONFIRMED THAT THE DATA WAS INDICATIVE OF A LEAD BREAK. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022, AND FUNCTIONED NORMALLY. THE PATIENT IS REPORTED AS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524040 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT INITIAL PLACEMENT OF THE RNS SYSTEM IN (B)(6) 2020. STARTING (B)(6) 2021, THE PATIENT REPORTED A SENSATION OF PAIN AROUND THE INCISION. THE AREA WAS PALPATED BY THE EPILEPTOLOGIST AND AN X-RAY WAS PERFORMED; HOWEVER NO CAUSE FOR THE SOURCE OF PAIN WAS IDENTIFIED. ON (B)(6) 2021, THE PATIENT UNDERWENT EXPLORATORY SURGERY. NO SIGNS OF INFECTION OR ISSUES WITH PRODUCT FIXATION WERE NOTED. THE LEAD FIXATION PLATE WAS REPLACED PROPHYLACTICALLY AND A SMALL AMOUNT OF BONE WAS SMOOTHED TO ALLOW THE LEAD LOCATED CLOSEST TO THE AREA OF THE PAIN TO SIT FLUSH. ON (B)(6) 2021, THE TREATING EPILEPTOLOGIST REPORTED THAT THE PAIN WAS STILL ONGOING. THE PATIENT UNDERWENT UNKNOWN PAIN CONTROL INJECTIONS AT THEIR PRIMARY PHYSICIAN'S OFFICE (DATE AND TYPE OF INJECTION NOT REPORTED). ON (B)(6) 2021, THE PATIENT WAS SEEN BY THE TREATING CLINICIAN AND REPORTED THAT THE PAIN CONTINUED TO PERSIST AT AND AROUND THE INCISION SITE. ADDITIONAL INTERVENTIONS AT THAT TIME INCLUDED A LOCAL ANESTHETIC AND STEROID INJECTION. A POSSIBLE ROUTE CAUSE OF THE PAIN WAS IDENTIFIED AS A SMALL NEUROMA AT THE INCISION SITE, BUT WAS NOT CONFIRMED. THE PATIENT WAS PRESCRIBED ORAL PAIN MEDICATIONS ON (B)(6

  Patient problems: Pain; Peripheral Nervous Injury

  MAUDE report 12232792 ↗
• MalfunctionJun 17, 2021Impedance Problem; Impedance Problem

  THE TREATING CLINICIAN PERFORMED A REVIEW OF THE PATIENT'S DEVICE DATA AND IDENTIFIED ABNORMAL IMPEDANCES AND ARTIFACT PRESENT ON THE RECORDED ECOGS ON (B)(6) 2020. RESPONSIVE STIMULATION WAS DISABLED ON CONTACT 2 OF THE AFFECTED LEAD. THE PATIENT'S RESPONSE WAS MONITORED UNTIL SUCH TIME THE CLINICIAN DEEMED A REPLACEMENT OF THE AFFECTED LEAD WAS NECESSARY. A LEAD REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITHOUT COMPLICATION. THERE IS NO CLEAR INDICATION OF HEAD TRAUMA OR OTHER INCITING EVENT. NO OTHER INFORMATION WAS REPORTED FROM THE TREATING CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018326 ↗
• MalfunctionMay 26, 2021Improper or Incorrect Procedure or Method; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SEEG LOCALIZATION TO ASSIST THE TREATING CLINICIANS IN DETERMINING IF THE PLACEMENT OF THE RNS SYSTEM LEADS SHOULD BE REVISED. AFTER COMPLETION OF SEEG LOCALIZATION, RNS SYSTEM IMPEDANCE MEASUREMENTS WERE TAKEN ALONG WITH A REAL-TIME ECOG. IMPEDANCE MEASUREMENTS SHOWED INSUFFICIENT CHARGE AND REAL-TIME ECOG SHOWED A FLAT SIGNAL. IMAGING INDICATED THAT ONE OF THE SEEG ELECTRODES INTERSECTED WITH THE RNS SYSTEM LEAD. BASED ON THIS INFORMATION, THE TREATING CENTER IDENTIFIED THAT THE SEEG LEAD PLACEMENT RESULTED IN THE BREAK OF THE RNS SYSTEM LEAD. STIMULATION AND DETECTION ON THE AFFECTED LEAD WAS DISABLED AND THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. THE AFFECTED LEAD WAS REPLACED ON (B)(6) 2021 WITHOUT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887267 ↗
• MalfunctionApr 19, 2021Signal Artifact/Noise; High impedance; Impedance Problem; Signal Artifact/Noise; High impedance; 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 11686558 ↗
• 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 (B)(6) 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 11441117 ↗
• MalfunctionNov 25, 2020High impedance; Deformation Due to Compressive Stress; Impedance Problem; High impedance; Deformation Due to Compressive Stress; Impedance Problem

  IN (B)(6) 2020 THE PATIENT REPORTED FEELING AN ELECTRIC SHOCK SENSATION AROUND HIS RIGHT EYE. THE TREATING CLINICIAN, IN CONJUNCTION WITH NEUROPACE FIELD SUPPORT, REVIEWED THE PATIENT'S ECOGS AND IDENTIFIED ARTIFACT WHICH WAS INDICATIVE OF A LEAD BREAK ON THE LEFT DEPTH LEAD. THE CLINICIAN REPROGRAMMED THE LEAD AND THE PATIENT REPORTED A DECREASE IN THE FREQUENCY AND SEVERITY OF THE SENSATION. IN (B)(6) 2020, THE CLINICIAN DISABLED DETECTION AND STIMULATION IN THE LEFT DEPTH LEAD WHICH WAS SUCCESSFUL IN ELIMINATING THE SENSATION. A LEAD REPLACEMENT WAS PERFORMED IN (B)(6) 2020 AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE NEUROSTIMULATOR. AFTER THE REPLACEMENT THERE HAVE BEEN NO REPORTS OF PAINFUL SENSATION AND THE LEAD IS FUNCTIONING AS INTENDED, PER THE TREATING CLINICIAN.

  Patient problems: Eye Pain; Pain

  MAUDE report 10899894 ↗
• MalfunctionNov 3, 2020High impedance; Impedance Problem; High impedance; Impedance Problem

  A REVIEW OF THE RECORDED ECOG DATA AND IMPEDANCE MEASUREMENTS ON PDMS CONFIRMED HIGH IMPEDANCES AND SIGNAL ARTIFACT ON THE LEFT DEPTH LEAD, SUGGESTIVE OF A LEAD BREAK. IT WAS UNCLEAR EXACTLY WHEN THE CHANGES OCCURRED BETWEEN FEBRUARY AND JUNE AS THE PATIENT WAS NOT REGULARLY USING HIS REMOTE MONITOR. THE PATIENT DID NOT RECALL FALLING IN BETWEEN THE TIME THAT THE SIGNAL CHANGES WERE NOTED ON THE DEPTH LEAD. A LEAD REPLACEMENT WAS PERFORMED AND A PORTION OF THE EXPLANTED LEAD WAS DISCARDED BY THE HOSPITAL. A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR WITHOUT COMPLICATIONS AND IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10782188 ↗
• MalfunctionSep 16, 2020High impedance; Impedance Problem; High impedance; Impedance Problem

  A REVIEW OF THE RECORDED ECOG DATA AND IMPEDANCE MEASUREMENTS ON PDMS CONFIRMED HIGH IMPEDANCES AND LOSS OF ECOG SIGNAL ON THE LEFT DEPTH LEAD, SUGGESTIVE OF A LEAD BREAK. NO INFORMATION REGARDING SEIZURE-RELATED TRAUMA OR OTHER FACTORS CONTRIBUTING TO OR RESULTING IN THE LEAD BREAK WERE PROVIDED BY THE TREATING CENTER. A LEAD REPLACEMENT WAS PERFORMED AND THE EXPLANTED LEAD WAS DISCARDED BY THE HOSPITAL, PER HOSPITAL POLICY. IN ADDITION, NO INFORMATION REGARDING THE CONDITION OF THE EXPLANTED LEAD WAS PROVIDED BY THE NEUROSURGEON PRIOR TO THE LEAD BEING DISCARDED. A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR WITHOUT COMPLICATIONS AND IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10544398 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED STARTING (B)(6) 2020 THEIR POST-SURGICAL HEADACHES WORSENED, AND NO RELIEF WAS BEING OBTAINED AFTER HAVING TRIED OVER-THE-COUNTER MEDICATIONS. A CT SCAN WAS PERFORMED ON (B)(6) 2020 AND SHOWED A 1.5 X 2.5 CM HEMORRHAGE SURROUNDING THE ELECTRODE IN THE RIGHT POSTERIOR TEMPORAL LOBE. THE PATIENT WAS SUBSEQUENTLY ADMITTED FOR FURTHER MONITORING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE TREATING CENTER. THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2020. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED THE PATIENT IS PROGRAMMED FOR DETECTION AND STIMULATION AND IS UPLOADING DATA AS EXPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9844995 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2019, THE PATIENT NOTED A PROTRUSION AND SOME FLUID LEAKING AROUND A PORTION OF THE RNS SYSTEM INCISION SITE. THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE ON (B)(6) 2020. DURING THE PROCEDURE, IT WAS DETERMINED THAT ONE OF THE UNCONNECTED, CAPPED LEADS WAS APPLYING OUTWARD PRESSURE NEAR THE INCISION LINE, PREVENTING PROPER HEALING. THE NEUROSURGEON RE-POSITIONED THE LEAD, SECURING IT AWAY FROM THE INCISION SITE. NO FURTHER INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: Impaired Healing; No Code Available; Patient Problem/Medical Problem

  MAUDE report 9614122 ↗
• MalfunctionJan 21, 2020Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  A SIGNAL ARTIFACT WAS NOTED ON THE RECORDED ECOGS DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2019 FOR THE LEFT DEPTH LEAD. THE PATIENT WAS REFERRED FOR X-RAYS (NEGATIVE FOR EVIDENCE OF A LEAD BREAK) AND NEUROSURGICAL CONSULT. A LEAD REVISION WAS PERFORMED ON (B)(6) 2019; HOWEVER LEAD IMPEDANCES WERE UNABLE TO BE MEASURED PRE-OP. VARIOUS TROUBLESHOOTING STEPS WERE PERFORMED DURING THE PROCEDURE, HOWEVER THE LEAD IMPEDANCES WERE STILL UNMEASURABLE. A KINK WAS NOTED IN THE REGION OF THE LEAD BODY NEAR THE DOG BONE. ONCE THE LEAD WAS STRAIGHTENED, THE LEAD WAS RE-TESTED; HOWEVER NO IMPEDANCE MEASUREMENTS WERE ABLE TO BE OBTAINED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED, CONNECTED AND TESTED WITH NO ISSUE. HOSPITAL POLICY REQUIRES EXPLANTED DEVICES DUE TO NON-ROUTINE CAUSES TO BE GIVEN TO THE RISK MANAGEMENT DEPARTMENT FOR ANALYSIS. THEREFORE THE EXPLANTED DEVICE IS UNABLE TO BE RETURNED TO NEUROPACE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612641 ↗
• MalfunctionDec 20, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  ON (B)(6) 2019, INTERMITTENT ARTIFACT WAS IDENTIFIED THROUGH ECOG REVIEW, SUGGESTIVE OF A POSSIBLE LEAD BREAK IN THE LEFT DEPTH LEAD CONNECTED TO PORT 2. FURTHER REVIEW OF THE LEAD IMPEDANCE AND ECOG DATA WAS PERFORMED AND WAS CONSISTENT WITH A LEAD BREAK. DURING A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT PROCEDURE, THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO PORT 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501373 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: Edema

  MAUDE report 9050426 ↗
• InjurySep 6, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  A REVIEW OF THE PATIENT'S ECOG DATA INDICATED SIGNAL ARTIFACT ON THE RIGHT DEPTH LEAD, SUGGESTIVE OF A POSSIBLE LEAD BREAK. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR REPROGRAMMING, AND DETECTION AND STIMULATION WERE DISABLED ON THE AFFECTED LEAD. THE PATIENT DENIED ANY SEIZURE-RELATED FALLS; HOWEVER THE NEUROSURGEON NOTED IT MAY BE RELATED TO SOME TYPE OF TRAUMA AS THE X-RAY INDICATED A VISIBLE KINK IN THE LEAD. THE RIGHT DEPTH LEAD WAS EXPLANTED ON (B)(6) 2019 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 8970375 ↗
• InjuryJun 14, 2019Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  DURING A ROUTINE REVIEW OF THE PATIENT'S NEUROSTIMULATOR ECOG DATA ON (B)(6) 2016, IT WAS NOTICED THAT THERE WAS A SIGNAL LOSS ON THE LEFT DEPTH LEAD. THE TREATING CLINICIAN STATED THAT THE PATIENT'S MOTHER INDICATED THAT THE PATIENT FELL FROM BED IN (B)(6). THE PATIENT WAS SEEN BY THE TREATING CENTER ON (B)(6) 2016 AT WHICH TIME STIMULATION WAS DISABLED ON THAT LEAD; HOWEVER STIMULATION REMAINED ENABLED ON THE OTHER LEAD AND THE PATIENT CONTINUED TO BE TREATED WITH RESPONSIVE STIMULATION. THE DEPTH LEAD WAS REPLACED ON (B)(6) 2019 DURING A ROUTINE BATTERY REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701930 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED IRRITATION AT THE RIGHT-SIDED BURR HOLE COVER (A NON-NEUROPACE PRODUCT) INCISION SITE. AFTER REVIEW BY THE TREATING CENTER, IT WAS DETERMINED THAT THE INCISION SITE HAD NOT HEALED PROPERLY. THE NEUROSURGEON EXPOSED THE NON-NEUROPACE BURR HOLE COVER AND FOUND THAT TWO OF THE SCREWS HAD COME LOOSE. THE TWO LOOSE SCREWS WERE REMOVED AND THE COVER REMAINS SECURED BY CALCIFICATION AND THE REMAINING SCREW. THE EVENT RESOLVED FOLLOWING THE SURGERY.

  Patient problems: Impaired Healing

  MAUDE report 8666609 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A HEADACHE ON (B)(6) 2019, THE DAY AFTER IMPLANT WITH THE RNS SYSTEM NEUROSTIMULATOR AND LEADS. FLUID LEAKAGE WAS OBSERVED FROM THE LEFT BURR HOLE COVER INCISION SITE AND WAS REPAIRED BY THE CENTER. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2019 FOR REMOVAL OF THE LEAD AND ADDITIONAL REPAIR OF THE CSF LEAK. PATIENT WAS DISCHARGED ON (B)(6) 2019. NO FURTHER DETAILS WERE PROVIDED BY THE TREATING CENTER.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8599731 ↗
• InjuryMar 13, 2019Break; High impedance; Break; High impedance

  A CHANGE IN THE SIGNALS FOR THE DEPTH LEAD CONNECTED TO PORT 1 OF THE RNS NEUROSTIMULATOR WAS NOTICED ON (B)(6) 2017. THE TREATING CENTER REPORTED THAT THE PATIENT HAD A POST-ICTAL ALTERCATION ON (B)(6) 2017 IN WHICH THE PATIENT'S HEAD HIT THE GROUND. ON (B)(6) 2018, DETECTION WAS DISABLED ON THE DEPTH LEAD CONNECTED TO PORT 1. DURING A ROUTINE NEUROSTIMULATOR REPLACEMENT ON (B)(6) 2019, THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE NEUROSTIMULATOR WITHOUT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417451 ↗
• InjuryDec 27, 2018Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  DURING A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT, THE SURGEON NOTED THAT IT APPEARED AS IF THE OUTER INSULATION LAYER WAS COMING OFF A SMALL REGION OF THE LEAD BODY, A FEW CENTIMETERS AWAY FROM THE NEUROSTIMULATOR ON THE LEAD CONNECTED TO PORT 1. THE SURGEON STATED THE INSULATION HAD PENETRATED INTO THE PATIENT'S SCALP AND CAUSED A SMALL WOUND . THE LEAD DEMONSTRATED NORMAL SIGNALS AND IMPEDANCE MEASUREMENTS UPON CONNECTION AND TESTING WITH THE NEW NEUROSTIMULATOR. FOR THIS REASON THE LEAD WAS NOT EXPLANTED. PRIOR TO CLOSING THE SCALP INCISION, THE SURGICAL SITE WAS IRRIGATED WITH PULSED LAVAGE, AND A PATCH OF DURA REGENERATION MATRIX WAS PLACED BETWEEN THE SCALP AND THE REGION OF THE LEAD BODY WHERE THE INSULATION LAYER WAS COMING OFF. NO ADDITIONAL INFORMATION NOR WERE ANY PICTURES OF THE AREA OF THE LEAD IN QUESTION WERE PROVIDED BY THE TREATING CENTER.

  Patient problems: Head Injury; Injury

  MAUDE report 8201779 ↗
• InjuryNov 13, 2018Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  BASED ON THE REVIEW OF THE PATIENT'S ECOGS BY THE TREATING CENTER, A SIGNAL ARTIFACT WAS IDENTIFIED ON THE RIGHT DEPTH LEAD INDICATING A POTENTIAL LEAD BREAK. PER THE TREATING CENTER, THE PATIENT FELL DUE TO A SEIZURE IN MAY 2018 AND HIT HER HEAD WHICH IS FELT TO BE THE PROBABLE CAUSE OF THE POSSIBLE LEAD BREAK. THE PATIENT DOES NOT FREQUENTLY INTERROGATE AND SYNCHRONIZE HER NEUROSTIMULATOR AND THEREFORE THIS ISSUE WAS NOT IDENTIFIED UNTIL (B)(6) 2018. DURING A ROUTINE NEUROSTIMULATOR REPLACEMENT ON (B)(6) 2018, THE LEAD WITH THE SIGNAL ARTIFACT WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064549 ↗
• InjuryMar 29, 2018Signal Artifact/Noise; Break; High impedance; Signal Artifact/Noise; Break; High impedance

  ON (B)(6) 2017 DURING A REVIEW OF NEUROSTIMULATOR DATA, AN ABNORMAL SIGNAL WAS OBSERVED ON THE DEPTH LEAD CONNECTED TO PORT 2 OF THE RNS NEUROSTIMULATOR. RESPONSIVE STIMULATION WAS DISABLED ON THAT LEAD AND A DECISION WAS MADE TO HOLD OFF ON REPLACING THE LEAD AT THAT TIME. ON (B)(6) 2018 THE PATIENT UNDERWENT A LEAD REVISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382545 ↗