NeuroPace® Cortical Strip Lead Kit CL-325-10-K (UDI 00855547005069)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00855547005069), received between Dec 10, 2015 and Feb 18, 2021 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION WITH THE RNS SYSTEM ON (B)(6) 2021. IMMEDIATELY POST-IMPLANT, THE PATIENT WAS NOT ABLE TO MOVE HIS CONTRALATERAL SIDE. SYMPTOMS STARTED AS DISTAL LEFT HAND WEAKNESS THAT PROGRESSED TO INVOLVE THE LEFT ARM AND LEG. A POSTOP CT WAS PERFORMED AND INDICATED A HEMORRHAGE NEAR THE LOCATION OF THE LEADS (APPROXIMATELY 1CM AWAY), LOCATED IN THE MOTOR CORTEX. THE SURGEON HYPOTHESIZED THAT THE BLEED MAY HAVE BEEN DUE A VESSEL WHICH RUPTURED FROM THE PRESSURE OF THE IMPLANTED LEADS AFTER SURGICAL CLOSURE. NO SURGICAL INTERVENTION WAS NECESSARY AND BY THE EVENING AFTER SURGERY, THE PATIENT DEMONSTRATED IMPROVEMENT IN ARM MOVEMENT. MULTIPLE POST-OP CTS WERE TAKEN AND NO CHANGES WERE SEEN IN THE SIZE/LOCATION OF THE BLEED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL.

  Patient problems: Intracranial Hemorrhage; Paresis

  MAUDE report 11346626 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE PATIENT PRESENTED WITH SEVERE HEADACHES AND SPEECH DIFFICULTY WHICH HAD STARTED TWO DAYS EARLIER. A BRAIN MRI WAS PERFORMED WHICH IDENTIFIED A LEFT PARIETAL INTRACEREBRAL HEMORRHAGE LOCATED BELOW OF THE SITE OF THE RNS SYSTEM LEADS). DIAGNOSED AS AN ACUTE CEREBRAL HEMORRHAGE. TREATMENT INCLUDED PROLONGED HOSPITALIZATION.

  Patient problems: Headache; Intracranial Hemorrhage; Speech Disorder

  MAUDE report 11280640 ↗
• InjuryDec 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT HAS A PRE-IMPLANT HISTORY OF NON-EPILEPTIC EVENTS WITH BILATERAL SENSORY PHENOMENA WITH NO ELECTROGRAPHIC CORRELATE SEEN ON RECORDED ECOGS AFTER IMPLANT WITH THE RNS SYSTEM. THE SYMPTOMS PROGRESSED POST-IMPLANT FROM BILATERAL SENSORY SYMPTOMS TO DISTAL LEFT HAND WEAKNESS WHICH SPREAD TO INVOLVE THE ENTIRE ARM. DUE TO THE PROGRESSION OF THE SYMPTOMS, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WHERE A HEAD CT WAS PERFORMED THAT IDENTIFIED AN INTRAPARENCHYMAL HEMORRHAGE LOCATED ADJACENT TO THE UNCONNECTED STRIP LEAD. MULTIPLE MRIS WERE PERFORMED 11/1/2020- 11/4/2020 WHICH INDICATED A CHANGE IN LOCATION OF THE UNCONNECTED STRIP LEAD SINCE INITIAL IMPLANT. ON 11/05/2020 THE PATIENT WAS TAKEN TO THE OR FOR SURGICAL EVACUATION OF THE HEMORRHAGE AND REMOVAL OF THE UNCONNECTED STRIP LEAD.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10953128 ↗
• MalfunctionAug 10, 2020Break; Impedance Problem; Break; Impedance Problem

  DURING A REVIEW OF RNS NEUROSTIMULATOR DATA BY THE TREATING CLINICIAN, ARTIFACT WAS OBSERVED ON THE ECOG RECORDED FROM THE LEFT STRIP LEAD , INDICATING A POTENTIAL LEAD BREAK. AFTER DISCUSSION WITH THE PATIENT, IT WAS DETERMINED THAT THIS SIGNAL CHANGE OCCURRED FOLLOWING A FALL DUE TO A SEIZURE, CONSISTENT WITH THE PATIENT'S PRE-IMPLANT SEIZURE SEMIOLOGY. THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE, WHICH WAS PERFORMED WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387984 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE PATIENT UNDERWENT RNS SYSTEM PLACEMENT ON (B)(6) 2019. IT WAS COMMUNICATED TO NEUROPACE THAT THE CORTICAL STRIP PLACEMENT WAS IMPEDED DURING THE PROCEDURE DUE TO THE STEREOTACTIC FRAME PLACEMENT. TWO CT SCANS WERE PERFORMED POST-PROCEDURE AND COMPARISON OF THE SCANS INDICATED THAT THE UNCONNECTED STRIP LEAD HAD MIGRATED. THE PATIENT WAS BROUGHT BACK TO THE OR FOR LEAD REPOSITIONING. NO FURTHER INFORMATION WAS PROVIDED BY THE TREATING CENTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252349 ↗
• MalfunctionDec 7, 2016Under-Sensing; Missing Value Reason; Under-Sensing; Missing Value Reason

  DURING THE CASE, THERE WAS NO REAL TIME ECOG SIGNAL OBSERVED ON CONTACTS 1 & 2 OF THE CORTICAL STRIP LEAD CONNECTED TO PORT 1. TROUBLESHOOTING WAS PERFORMED AND THE LEAD WAS MOVED TO OTHER LOCATIONS ON THE CORTICAL SURFACE OF THE BRAIN WITH NO REAL TIME ECOG SIGNAL OBSERVED. THE LEAD WAS THEN CLEANED AND PLACED IN PORT 2 TO CONFIRM LEAD VS NEUROSTIMULATOR ISSUE AND WITH THE SAME RESULT OF NO SIGNAL OBSERVED ON CONTACTS 1 AND 2. OTHER LEADS THAT WERE IMPLANTED WERE CONNECTED AND WE OBSERVED GOOD RECORDING THROUGHOUT THE SYSTEM. THE NEUROSURGEON REMOVED THE CORTICAL STRIP LEAD IN QUESTION AND IMPLANTED A NEW CORTICAL STRIP LEAD . ALL CONTACTS ON THIS NEW LEAD RECORDED PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6150953 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2016 - PATIENT WAS IMPLANTED WITH THE RNS SYSTEM INCLUDING THE NEUROSTIMULATOR, CONNECTED LEADS INCLUDE A DEPTH LEAD (DL) (LEFT TEMPORAL HETEROTOPIA) AND CORTICAL STRIP LEAD CL ((B)(4), LEFT PARIETAL-SUPERIOR). NOT CONNECTED CL (SN (B)(4), LEFT PARIETAL INFERIOR). (B)(6) 2016 - THE PATIENT PRESENTED TO CLINIC ON (B)(6) 2016 BECAUSE HE DEVELOPED SUDDEN ONSET RIGHT HAND WEAKNESS ON (B)(6) WHICH PROGRESSIVELY GOT WORSE OVER THE NEXT THREE DAYS. WEAKNESS PRESENTED AS FOLLOWS: RIGHT UPPER EXTREMITY WEAKNESS. HE WAS UNABLE TO NEITHER HOLD A TOOTHBRUSH NOR FEEL HIS HAND. HE CAME IN AND HAD NUMBNESS IN HIS RIGHT 3RD, 4TH, AND 5TH DIGIT. RIGHT UPPER EXTREMITY FOR HIS MOTOR EXAM WAS ALL 4 OUT OF 5 (DELTOID, TRICEP, BICEP, HAND GRIP). HE HAD REPORTED THAT HE HAD BUMPED HIS HEAD ON THE TRACTOR ((B)(6)) AND HAD A MILD HEADACHE THEREAFTER WITH SOME SCALP TENDERNESS BUT NO ISSUES AROSE UNTIL (B)(6). HE WAS TAKEN TO THE OR FOR EXPLORATORY SURGERY WHICH REVEALED A SMALL SUBDURAL HEMATOMA FOUND ON TOP OF ONE OF THE SUBDURAL STRIPS. IT IS NOT CLEAR IF IT WAS THE CONNECTED OR NON-CONNECTED STRIP. THE CORTICAL STRIP LEADS WERE EXPLANTED, THE LEFT HIPPOCAMPAL DEPTH ELECTRODE REMAINS IMPLANTED, CO

  Patient problems: Hematoma; Weakness

  MAUDE report 5967709 ↗
• InjuryMar 15, 2016Device Remains Activated; Device Remains Activated

  THE PATIENT REPORTED CLUSTERS SEIZURES (MORE INTENSE AURAS) AND SEVERE HEADACHE AND WAS ADMITTED INTO THE EMU ON (B)(6) 2016. A CT SCAN WAS PERFORMED AND THE SITE OBSERVED AN ACUTE INTRAPARENCHYMAL HEMORRHAGE IN THE RIGHT PARIETAL LOBE IMMEDIATELY SUPERIOR TO THE MOST SUPERIOR STRIP AND ADJACENT TO THE PRIOR CRANIOTOMY. AN ANGIOGRAM WAS PERFORMED THAT CONFIRMED AN ARTERIOVENOUS (AV) FISTULA ON (B)(6) 2016 AND SHE WAS TAKEN BACK FOR A FOLLOW UP ANGIOGRAM ON (B)(6) 2016 WHICH NO LONGER REVEALED THE PRESENCE OF THE AV FISTULA. THE OPINION OF THE SURGEONS WAS THAT THE AV FISTULA THROMBOSED ON ITS OWN. THE DOCTOR IS NOT TAKING ANY ACTION AT THIS TIME AND FOLLOW UP CT SCAN IS PLANNED FOR TWO WEEKS FROM NOW. THE LEADS WERE IMPLANTED AFTER PHASE II INTRACRANIAL MONITORING ((B)(6) 2015) AND THE NEUROSTIMULATOR WAS IMPLANTED A MONTH LATER ((B)(6) 2015) THE RNS SYSTEM REMAINS IMPLANTED AND PROGRAMMED FOR DETECTION AND TREATMENT

  Patient problems: Intracranial Hemorrhage

  MAUDE report 5502864 ↗
• InjuryDec 10, 2015High impedance

  PATIENT WAS IMPLANTED WITH A NEUROPACE NEUROSTIMULATOR AND ONE NEUROPACE DEPTH LEAD AND ONE NEUROPACE CORTICAL STRIP LEAD ON (B)(6) 2015. THE PATIENT BEGAN COMPLAINING OF HEADACHES IN (B)(6) 2015. THE CENTER REVIEWED THE PATIENTS STORED ECOGS ON THE NEUROPACE PATIENT DATA MANAGEMENT SYSTEM AND NOTED SEVERAL STORED ECOGS WITH HIGH AMPLITUDE ARTIFACT. THE PATIENT WAS SEEN BY THE CENTER AND THE PHYSICIAN PERFORMED PALPATION OF THE SCALP IN THE VICINITY OF THE LEAD LOCATION AND WAS ABLE TO DUPLICATE SIMILAR HIGH AMPLITUDE ARTIFACT ON THE REAL TIME ECOG. REVIEW OF HISTORICAL LEAD IMPEDANCES SHOWED AN INCREASE IN LEAD IMPEDANCES ON THE CORTICAL STRIP LEAD. PHYSICIAN ALSO PERFORMED TEST STIMULATION AND AT HIGHER CURRENTS THE PATIENT COMPLAINS OF PINCHING SENSATION AT LEAD SITE. PATIENT HAD A CT SCAN PERFORMED AND NO EVIDENCE OF A BLEED OR OTHER ABNORMALITY. EVIDENCE SUGGESTS A LEAD BREAKAGE BUT WERE UNABLE TO CONFIRM VIA A CT SCAN. THE ARTIFACT APPEARS TO OCCUR INFREQUENTLY ON STORED ECOGS. UNABLE TO DETERMINE THE CAUSE OF THE HEADACHE AT THIS TIME

  Patient problems: Headache

  MAUDE report 5285233 ↗