CereLink™ 826851Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10381780520689), received between Dec 30, 2021 and Apr 10, 2026 — classified as 73 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026No Device Output

  A FACILITY REPORTED A CERELINK SENSOR (ID: 826851) WAS IMPLANTED. THE DEVICE STOPPED READING AFTER BEING IMPLANTED FOR SEVERAL DAYS, WHILE THE NURSING STAFF WAS BOOSTING PATIENT IN BED. SENSOR WAS NOT RETRIEVED DUE TO THE EVENT. ADDITIONAL INFORMATION: IMPLANT LOCATION (EX: PARENCHYMA): PARENCHYMA. WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES. IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: DRAGER. WAS THE PATIENT LEAD ALWAYS CONNECTED: MOST OF TIME, RN DID NOT IT CAME OFF AROUND THE TIME OF FAILURE WHILE BOOSTING PATIENT IN BED. WHAT WAS HAPPENING WITH PATIENT: SENSOR MOMENTARILY SHOWED 149 FOR ICP, THEN IMMEDIATELY WENT INTO CABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 24843968 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712075 ↗
• InjuryFeb 6, 2026Improper or Incorrect Procedure or Method

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278014 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 4 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015, 3013886523-2026-00016, 3013886523-2026-00017. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: - IMPLANT LOCATION - "PARENCHYMA" - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR" - WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278012 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 5 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015 3013886523-2026-00016, 3013886523-2026-00017, 3013886523-2026-00018. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: IMPLANT LOCATION - "PARENCHYMA" WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR." WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278008 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 2 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015, 3013886523-2026-00017, 3013886523-2026-00018, 3013886523-2026-00019. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: - IMPLANT LOCATION - "PARENCHYMA" - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR" - WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277682 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277673 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277660 ↗
• InjuryJan 28, 2026Insufficient Device Problem Information

  A FACILITY REPORTED A CERELINK ICP PROBE BOLT (ID: 826851) FAILED REQUIRING REMOVAL AND INSERTION OF A NEW BOLT AND SENSOR. ADDITIONAL INFORMATION: WAS THE PATIENT LEAD (ELECTRODE OF EXTENSION CABLE) ALWAYS CONNECTED TO THE PATIENT? "YES". IMPLANT LOCATION (EX: PARENCHYMA)? "RIGHT SIDE". WHAT WAS THE USER DOING (E.G., POWERING UNIT, ZEROING SENSOR, SETTING ALARM, DOWNLOADING DATA)? "NOTHING". WHAT WAS HAPPENING WITH PATIENT (E.G., TRANSPORT, MRI, CT)? "PATIENT WAS BEING TURNED WHEN SENSOR FAILED".

  Patient problems: Insufficient Information

  MAUDE report 24199814 ↗
• InjuryJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK MICROSENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2025. THE DEVICE REPORTEDLY DISPLAYED INACCURATE READINGS THAT DID NOT CORRELATE WITH INTRACRANIAL PRESSURE (ICP) VALUES OBTAINED FROM AN ACCUDRAIN DEVICE. DURING IMPLANTATION, AN INCORRECT DRILL BIT, RATHER THAN THE DRILL BIT PROVIDED IN THE BOLT KIT, WAS REPORTEDLY USED, RESULTING IN AN INCOMPATIBLE DRILLED HOLE AND METAL BOLT. THE MICROSENSOR WAS SUBSEQUENTLY INSERTED. THE BOLT WAS THEN REMOVED AND REINSERTED CORRECTLY ON A SECOND ATTEMPT; HOWEVER, THE MICROSENSOR WAS NOT REPLACED FOLLOWING REMOVAL, DESPITE THE DEVICE INSTRUCTIONS INDICATING THAT THE MICROSENSOR SHOULD BE REPLACED AFTER REMOVAL. ON (B)(6) 2025, FOLLOWING A COMPUTED TOMOGRAPHY (CT) SCAN, THE RECEIVING NEUROSURGEON REPORTED ELEVATED ICP READINGS FROM THE MICROSENSOR. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED FOR COMPARISON AND REPORTEDLY MEASURED ICP VALUES RANGING FROM 8 TO 20 MMHG, WHILE THE CERELINK MICROSENSOR REPORTEDLY DISPLAYED PRESSURES IN THE 30S TO THE 50S MMHG. UPON REMOVAL OF THE MICROSENSOR, DEBRIS WAS REPORTEDLY OBSERVED NEAR THE TIP OF THE DEVICE. THE MICROSENSOR WAS REMOVED BECAUSE THE REPORTED READINGS WERE CONSIDE

  Patient problems: Insufficient Information

  MAUDE report 24034513 ↗
• InjuryJan 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: Insufficient Information

  MAUDE report 23957137 ↗
• InjuryJan 2, 2026Non Reproducible Results

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23943166 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657682 ↗
• MalfunctionNov 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555444 ↗
• InjuryOct 10, 2025Incorrect Measurement; Incorrect Measurement

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23266832 ↗
• InjurySep 5, 2025No Device Output; No Device Output

  A HEALTHCARE FACILITY REPORTED A CERELINK SENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2025. FOLLOWING IMPLANTATION, THE INTRACRANIAL PRESSURE (ICP) READING SPONTANEOUSLY DROPPED TO 0, AND NO WAVEFORM WAS OBSERVED. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION, AND NO MANIPULATION OF THE MONITOR WAS PERFORMED. THE ICP MONITOR WAS CHANGED; HOWEVER, THE SAME 0 ICP READING AND ABSENCE OF WAVEFORM PERSISTED. THIS ISSUE CONTINUED FOR A DURATION OF 40 HOURS. NOTABLY, THE FIRST ICP MONITOR WAS USED THE SAME ISSUE WITHIN 24 HOURS OF SENSOR INSERTION. THE SENSOR WAS REMOVED ON (B)(6) 2025, AND WAS NOT REPLACED. ADDITIONAL INFORMATION: - IMPLANT LOCATION - "PARENCHYMA". - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - YES - PHILLIPS MX800. - WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES". - DESCRIPTION OF THE FAILURE: - "READING LOW/NEGATIVE NUMBERS. MINIMAL IF NO CHANGE DURING CARE AND REPOSITIONING, SUSPICIOUS OF ACCURACY. SPONTANEOUS 0 WITH NO WAVEFORM." - "INSERTED (B)(6), 1ST NEGATIVE NUMBERS VIEWED AUG 14 FOR 4 HRS., THEN 3 MORE TIME".

  Patient problems: Insufficient Information

  MAUDE report 22978148 ↗
• InjurySep 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A MICROSENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2025. AFTER TRANSFER TO THE ICU (INTENSIVE CARE UNIT), THE ICP (INTRACRANIAL PRESSURE) WAS READING NEGATIVE NUMBERS AND OCCASIONALLY FLUCTUATED UP TO 73MMHG. A GOOD WAVEFORM WAS PRESENT, BUT THE ICP READING WAS NOT ACCURATE. ON THE ANALYTICS PAGE IT IDENTIFIES THE SENSOR AS ZEROED WITH THE DATE AND TIME. WHEN GOING TO THE ZERO SENSOR SCREEN THERE IS A MESSAGE SAYING, ¿SENSOR NOT ZEROED¿. THEREFORE, THE SENSOR WAS REMOVED AND REPLACED ON (B)(6) 2025. THE CABLE USED WAS ICP EXPRESS CABLE (ID (B)(6)). ADDITIONAL INFORMATION: - IMPLANT LOCATION: "PARENCHYMA". - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: "YES". - IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: "PHILIPS (MODEL UNKNOWN)". - WAS THE PATIENT LEAD ALWAYS CONNECTED: "YES".

  Patient problems: Insufficient Information

  MAUDE report 22978147 ↗
• InjurySep 5, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  A NURSE REPORTED A CERELINK SENSOR (ID 826850) WAS IMPLANTED IN A 54-YEAR-OLD MALE PATIENT WHO HAD EXPERIENCED A HEMORRHAGIC STROKE INVOLVING THE BASAL GANGLIA. ON AUGUST 16, WHILE THE BEDSIDE NURSE WAS REPOSITIONING THE PATIENT TO CHANGE THE LINENS, THE CERELINK MONITOR BEGAN ALARMING. THE ERROR CODE DISPLAYED WAS: ¿SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR.¿ THE NURSE FOLLOWED STANDARD TROUBLESHOOTING PROCEDURES. SHE CONFIRMED THAT THE EKG LEAD WAS INTACT AND SECURE, THOUGH SHE REPLACED IT AS A PRECAUTION. SHE THEN POWERED OFF THE MONITOR AND REBOOTED IT THREE TIMES, BUT THE SAME ERROR CODE CONTINUED TO APPEAR. SHE CHECKED THE CONNECTION BETWEEN THE ICP EXTENSION CABLE AND THE MICROSENSOR, WHICH WAS SECURE. DESPITE REPLACING THE ICP EXTENSION CABLE, THE ERROR PERSISTED, AND THE ALARM CONTINUED TO SOUND. THE SENSOR WAS ORIGINALLY IMPLANTED ON (B)(6) 2025, AND REMOVED ON AUGUST 16, 2025. THE PATIENT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS RELATED TO THE DEVICE ISSUE. AS OF THE LATEST UPDATE, THE PATIENT REMAINS IN CRITICAL BUT STABLE CONDITION FOLLOWING THE BASAL GANGLIA BLEED. ADDITIONAL INFORMATION: IMPLANT LOCATION: "TUNNELED - PARENCHYMA" WAS THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977789 ↗
• InjuryAug 21, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864811 ↗
• InjuryJul 25, 2025No Device Output; No Device Output

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00199. A FACILITY REPORTED A CERELINK SENSOR (ID 826851) WAS PLACED ON (B)(6) 2025, CONNECTED TO A PHILIPS MONITOR CABLE (ID 826881). THE PATIENT EXPERIENCED A TRAUMATIC BRAIN INJURY (TBI), WHO ALSO HAD A DRAIN AND WAS INTUBATED. THE BEDSIDE NURSE REPORTED THAT THE MONITOR STOPPED WORKING WHEN SHE LAID A BLANKET OVER THE PATIENT. THE PATIENT HAD NOT BEEN TRANSPORTED AND WAS IN A PHENOBARBITAL-INDUCED COMA. THE ACCOUNT MANAGER STATED: "I ASKED THE NURSE TO SHOW ME THE TREND SCREEN, I DIDN¿T SEE THE 'LINE' THAT TYPICALLY INDICATES AN ESD SHOCK, WHICH I WAS INSTRUCTED TO LOOK FOR. THE NURSE TURNED OFF THE MONITOR AND DISCONNECTED IT FROM THE PATIENT FOR 30 MINUTES, THEN ATTEMPTED TO RECONNECT IT, BUT WAS UNSUCCESSFUL. THE REFERENCE LEAD WAS ATTACHED. THE NURSE ALSO TRIED SWAPPING OUT THE ENTIRE MONITOR AND CORD, BUT THE SENSOR STILL DID NOT WORK." IT WAS ALSO NOTED THAT "THE NURSE WAS VERY CLEAR THAT THIS COULD HAVE CAUSED AN INJURY IF THE SENSOR HAD NOT BEEN IN PLACE FOR SO LONG." DUE TO THE ISSUE, THE SENSOR WAS REMOVED. ADDITIONAL INFORMATION: IMPLANT LOCATION: "PARENCHYMAL" HOSPITAL LOCATION OF IMPLANT: "OPERATIN

  Patient problems: Insufficient Information

  MAUDE report 22608772 ↗
• InjuryJun 23, 2025Output Problem; Output Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310408 ↗
• MalfunctionMay 21, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  A FACILITY REPORTED: WHEN A SENSOR (ID 826851) WAS INSERTED, THE CERELINK MONITOR GAVE ERROR MESSAGE "SENSOR OR CABLE FAULTY" NURSES TRIED CHANGING ICP MONITOR (826820) AND ICP EXTENSION CABLE (826845) BUT NOTHING WORKED. AFTER TAKING A NEW STERILE SENSOR EVERYTHING WORKED FINE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY DUE TO PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061373 ↗
• InjuryMar 21, 2025Incorrect Measurement; Incorrect Measurement

  1 OF 3 REPORTS: OTHER MFG REPORT NUMBERS: 3014334038-2025-00039, 3014334038-2025-00040. A FACILITY REPORTED: "CODMAN MEASUREMENT DOES NOT WORK. MUST BE RESET MULTIPLE TIMES. PATIENT CRITICALLY ILL WITH LABILE ICP WITHOUT POSSIBILITY OF MEASUREMENT ON EVD. CODMAN CHANGED X 3 DURING DAY SHIFT AND BEGINNING OF EVENING SHIFT. MEASUREMENT IS SEEN AT ONE POINT ON CODMAN, BUT CANNOT BE DISPLAYED ON SCREEN." "FINALLY, WITH THE HELP OF THE ANESTHESIA NURSE (FETCHED SEVERAL CODMAN) IT IS POSSIBLE TO GET THE CORRECT MEASUREMENTS. DURING SHIFT, PATIENT HAS DEVELOPED PUPIL DIFF DUE TO INCREASING EDEMA AND CODMAN HAS NOT SHOWN CORRECT MEASUREMENT. NEITHER ON CODMAN NOR SCREEN." PATIENT WAS URGENTLY TAKEN TO THE OR FOR EVD PLACEMENT. CONSEQUENCE OF THE INCIDENT: MEDICAL OR SURGICAL TREATMENT. WERE OTHER MEDICAL DEVICES USED IN CONNECTION WITH THE INCIDENT (E.G. ACCESSORIES)? YES. SEVERAL SERIAL NUMBERS IN USE IN THE DEPARTMENT: (B)(6), ETC. CABLES TO AND FROM THE ICP ELECTRODE IN THE BRAIN AND THE ONE OUT TO THE SCREEN CAN BE REPLACED BETWEEN THE DIFFERENT ICP MONITORS. ICP SENSOR (THE ELECTRODE IN THE BRAIN) THAT CONNECT TO THE ICP MONITOR: CERELINK (TM) ICP SENSOR, REFERENCE NUMBER (B)(4).

  Patient problems: Cerebral Edema

  MAUDE report 21664949 ↗
• InjuryFeb 14, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A FACILITY REPORTED A CERELINK SENSOR (B)(6) WAS IMPLANTED AND ERROR MESSAGE "SENSOR OR EXTENSION CABLE FAILURE" APPEARED SPONTANEOUSLY WITHOUT REASON. THE PATIENT WAS NOT MOVED. MEDICAL STAFF CHANGED THE MONITOR AND CABLE WITHOUT SUCCESS. THEREFORE, THE SENSOR WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION RECEIVED: THE NEW SENSOR WORKED WITHOUT CHANGING MONITOR OR CABLE. ELECTRODE OF EXTENSION CABLE WAS PLACED ON THE PATIENT DURING ALL MONITORING, INTRAPARENCHYMAL LOCALIZATION IN THE LEFT FRONTAL REGION, NO CLEAR DELAY (FIBER CHANGED IN 30 MINUTES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384769 ↗
• InjuryFeb 11, 2025Protective Measures Problem; Protective Measures Problem

  A PHYSICIAN REPORTED A CERELINK SENSOR (B)(6) WAS IMPLANTED AND WORKING APPROPRIATELY. AFTER RETURNING FROM COMPUTED TOMOGRAPHY (CT) SCAN THE NURSE PLUGGED IN THE MICROSENSOR AND ZEROED THE MICROSENSOR WHILE IT WAS IN THE HEAD. THE ZERO BUTTON FOR THE MICROSENSOR IN THE CERELINK MONITOR ALLOWED ZEROING EVEN THOUGH THE SENSOR WAS IMPLANTED. DUE TO THE ISSUE, THE SENSOR WAS REMOVED AND REPLACED. THE PATIENT WAS DISCHARGED, AND INTRACRANIAL PRESSURE (ICP) MEASURING IS NO LONGER NEEDED. CLINICAL QUESTIONNAIRE: MONITOR USED AND SERIAL NUMBER: CERELINK (B)(6). SENSOR INFORMATION: A. KIT USED: (B)(6). D. IMPLANT LOCATION: PARENCHYMA. WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR (YES/NO): YES. A. IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: PHILIPS. WAS THE PATIENT LEAD ALWAYS CONNECTED (YES/NO): YES. DESCRIPTION OF THE FAILURE INCLUDING: PROVIDER HAD PLACED A CERELINK MICROSENSOR PRIOR. THE MICROSENSOR WAS ZEROED AND WORKING APPROPRIATELY. AFTER RETURNING FROM CT THE NURSE PLUGGED IN THE MICROSENSOR AND ZEROED THE MICROSENSOR WHILE IT WAS IMPLANTED. THE ZERO BUTTON (FOR THE MICROSENSOR) WAS MADE AVAILABLE EVEN THOUGH IT WAS IMPLANTED AND PRESSURE WAS BEING APPLIED TO

  Patient problems: Insufficient Information

  MAUDE report 21357510 ↗