CereLink™ 826850Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10381780520672), received between Dec 3, 2021 and Mar 13, 2026 — classified as 2 deaths, 76 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (41 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 12, 2025Open, Classified

   Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

   Z-1037-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3006697299-2026-00024, 3014334038-2026-00025. A FACILITY REPORTED: THE MONITORED ICP PRESSURE READINGS GETTING LOWER AND LOWER UNTIL IT DISAPPEARS FROM THE MONITOR SCREEN ALL TOGETHER. IT WAS RE-CALIBRATED AND FUNCTIONALLY CHECKED & TESTED USING AN IN-HOUSE TEST SENSOR AND ALL SEEMS TO BE WORKING CORRECTLY. PATIENT PRESSURES READING 28. MONITOR SPONTANEOUSLY SHOWED VARYING PRESSURES FROM MINUS 20 TO PLUS10. MESSAGE: "POSSIBLE INPUT FAILURE. VERIFY SENSOR,CABLE, AND LEAD CONNECTIONS". THE EARTHING WIRE WAS ATTACHED TO THE PATIENT. THEN THE MESSAGE: "PATIENT MONITOR CONNECTION ERROR, RECONNECT MONITOR AGAIN"; PATIENT WAS NEVER DISCONNECTED. THEN MONITOR SHOWED NO PRESSURE READINGS. MOVED PATIENTS HEAD AND PRESSURES REAPPEARED. THEN NUMERICAL PRESSURES DISAPPEARED AGAIN. MONITOR RE-ZEROED AND TURNED OFF AND ON. MESSAGE: "POSSIBLE INPUT FAILURE VERIFY SENSORS,CABLES AND LEAD CONNECTIONS" REAPPEARED. THERE WAS ALWAYS A CONTINOUS ERROR MESSAGE THROUGHOUT THE INCIDENT. EVD TRANSDUCED AND SHOWED ICPS 18. MEDIC NOTIFIED AND REFERRAL TO NEUROSURGEONS, EVD HAD BEEN TRANSDUCED EARLIER TO CHECK PRESSURE AND AT THAT POINT BOTH THE CERELINK AND EVD PRESSU

  Patient problems: Insufficient Information

  MAUDE report 24592625 ↗
• MalfunctionMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID 826850) FAILED WHILE IN USE. LOOKING THROUGH THE ERROR LOGS IT WAS FOUND MULTIPLE "SENSOR WARNING: MEAN ICP VALUE EXCEEDED THE VALID RANGE:" MESSAGES. THE RECORDED VALUES ARE BETWEEN -84 TO -360MMHG. PATIENT REQUIRED AN MRI SCAN OF HEAD. ICP MONITOR IN SITU WHICH REQUIRED GAUZE AND COILING AWAY FROM THE SKIN PRE SCAN. THIS WAS DONE INCORRECTLY AND NEEDED RE-DOING MULTIPLE TIMES LEADING TO HIGHER RISK OF DISLODGEMENT. PATIENT ADMITTED TO HOSPITAL WITH A INTRAPARENCHYMAL BLEED AND HAS THE ICP MONITOR IN STILL (24 DAYS) DUE TO CONTINUING ICP SPIKES AND HYDROCEPHALUS. MRI COMPLETED SAFELY HOWEVER ICP NOW READING NEGATIVE NUMBERS AND IS NOT SUTURED IN. ?ACCIDENTALLY DISLODGED OR MOVED SLIGHTLY. ADDITIONAL INFORMATION RECEIVED: - SENSOR REFERENCE? 826850 - SENSOR LOT NUMBER? UNKNOWN - EXTENSION CABLE LOT NUMBER? UNKNOWN - DATE OF EVENT? 18/02/2026 - WAS THE PATIENT LEAD (ELECTRODE OF EXTENSION CABLE) ALWAYS CONNECTED TO THE PATIENT? YES - IMPLANT LOCATION - PARENCHYMAL - DID THE ISSUE LEAD TO ANY PATIENT INJURY / COMPLICATIONS OR DEATH?ANSWER : NO - DID THE ISSUE LEAD TO A CRITICAL DELAY IN PATIENT CARE ? NO - WHAT WAS THE USER DOING (E.G., POWER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586643 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507137 ↗
• InjuryFeb 27, 2026Output Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469568 ↗
• InjuryJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID: 826851) WAS IMPLANTED. THE CERELINK MONITOR REGISTERED MULTIPLE ISOLATED ABNORMAL READINGS, WITH SEVERAL PEAKS REACHING THE 70 MMHG RANGE AS WELL AS OCCASIONAL LOW VALUES AROUND 3 MMHG. THESE EVENTS WERE BRIEF AND SPORADIC, NOT SUSTAINED AND DID NOT FORM A CONTINUOUS TREND IN THE DATA. NO EVD WAS IMPLANTED. ADDITIONAL INFORMATION: PLEASE CONFIRM IF THE ISSUE WAS DETECTED BEFORE, DURING OR AFTER IMPLANTATION: AFTER. DID THE PATIENT EXPERIENCE ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE? UNKNOWN. WAS THE SENSOR REPLACED? SENSOR WAS NOT REPLACED. WAS THE SENSOR REMOVED DUE TO FAILURE OR MONITORING WAS NO LONGER NEEDED? REMOVED DUE TO ABNORMAL READINGS. WITH PEAKS REACHING 70 MMHG. WAS THE INTEGRA/CODMAN MONITOR CONNECTED TO A PATIENT MONITOR? YES. IF YES, PROVIDE MONITOR MAKE AND MODEL: PHILLIPS X3. WAS THE PATIENT LEAD ALWAYS CONNECTED? YES.

  Patient problems: Insufficient Information

  MAUDE report 24199815 ↗
• InjuryJan 28, 2026Nonstandard Device

  THE FACILITY REPORTED A CERELINK MONITOR GENERATED A ¿SENSOR FAIL¿ ALARM DURING PATIENT MONITORING. THE CERELINK SENSOR (ID UNKNOWN) HAD BEEN PLACED IN THE OPERATING ROOM AND INITIALLY FUNCTIONED AS EXPECTED; HOWEVER, AFTER APPROXIMATELY 12 HOURS OF USE, THE MONITOR DISPLAYED A SENSOR/CABLE FAILURE MESSAGE THAT STAFF WERE UNABLE TO RESOLVE. THE REFERENCE LEAD WAS CONFIRMED TO HAVE BEEN ATTACHED AT THE TIME OF USE. THE SENSOR WAS NOT REPLACED, AS THE PATIENT HAD EXPIRED. THEY DID NOT CONTACT TECHNICAL SUPPORT FOR TROUBLESHOOTING AT THE TIME OF THE EVENT. FOLLOWING THE INCIDENT, THEY REMOVED THEIR CERELINK MONITORS FROM SERVICE AND REDEPLOYED ICP EXPRESS MONITORS. THE FACILITY ALSO REPORTED SEVERAL PREVIOUS CERELINK SENSOR ISSUES IN RECENT WEEKS AND SUBSEQUENTLY PROVIDED MULTIPLE DATA FILES FROM THE AFFECTED MONITOR FOR REVIEW. THE CABLE USED DURING THE EVENT WAS IDENTIFIED AS A PRESSURE OUTPUT CABLE ¿ GE (ID: 826882). ADDITIONAL INFORMATION: - IMPLANT LOCATION: PARENCHYMA - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES - IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: GE CARESCAPE - WAS THE PATIENT LEAD ALWAYS CONNECTED: YES - CAUSE OF DEATH: - GUNSHOT WOUND (

  Patient problems: Insufficient Information

  MAUDE report 24199810 ↗
• InjuryJan 21, 2026Nonstandard Device

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 24130108 ↗
• InjuryDec 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23824796 ↗
• InjuryDec 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23824795 ↗
• InjuryNov 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 23657880 ↗
• InjuryNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID: 826850) WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. AFTER IMPLANTATION, WHEN MOVING THE PATIENT TO THE BED, THE CERELINK PICTURE FROZE AND THEY ONLY SAW A WRONG ICP NUMBER AND NO WAVEFORM. MEDICAL STAFF TRIED TO SWITCH THE MONITOR AND THE CABLE BUT STILL NO CONNECTION, THEREFORE, THE PATIENT WAS TAKEN AGAIN TO OPERATIVE ROOM TO HAVE THE SENSOR REMOVED AND REPLACED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23617134 ↗
• MalfunctionOct 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379901 ↗
• MalfunctionSep 26, 2025Incorrect Measurement; Incorrect Measurement

  A SALES REPRESENTATIVE REPORTED: "THE PRESSURE SENSOR WAS INSTALLED ON SATURDAY EVENING. INITIALLY, THERE WAS A VERY NICE CURVE (I WAS THERE). NOW, LESS THAN 48 HOURS LATER, FLATTENED CURVE WENT DOWN TO A PRESSURE OF -6. NEGATIVE PRESSURES IN THE HEAD ARE OBVIOUSLY NOT POSSIBLE. IT IS ALSO NOTICEABLE IN OUR EMV THAT THERE WAS A SUDDEN DROP FROM (WHAT I CONSIDER TO BE ADEQUATE PRESSURES OF) 5-8 TO 0 TO -1 OVER THE COURSE OF YESTERDAY. AND NOW IT HAS DROPPED EVEN FURTHER TO -6. THE MONITORING COULDN'T BE TRUSTED: SO WE HAD TO TRANSFER OUR VENTILATED PATIENT MORE OFTEN TO RADIOLOGY, PLUS THERE WAS NO RELIABLE CONTINUOUS MONITORING OF THE ICP." THE PATIENT HAD MORE FREQUENT CTS SCANS DUE TO PRODUCT PROBLEM AS THE VENTRICLES WERE TOO COMPRESSED TO INSERT AN EVD. PATIENT WAS MONITORED DUE TO SEVERE CEREBRAL MALARIA WITH CEREBRAL EDEMA.

  Patient problems: Insufficient Information

  MAUDE report 23154503 ↗
• MalfunctionSep 19, 2025Failure to Transmit Record; Failure to Transmit Record

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23095857 ↗
• MalfunctionSep 19, 2025Failure to Transmit Record; Audible Prompt/Feedback Problem; Failure to Transmit Record; Audible Prompt/Feedback Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23095837 ↗
• InjuryAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22911714 ↗
• MalfunctionAug 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PHYSICIAN REPORTED A CERELINK SENSOR (ID: 826850) VALUE WAS "HIGHER THAN +4 OR MORE" BUT DOES NOT REMEMBER HOW MUCH. PHYSICIAN WAS INFORMED THAT EVD VENTRICULAR ICP READING COULD BE LOWER THAN PARENCHYMAL CERELINK MICROSENSOR READING DUE TO PHYSIOLOGICAL DIFFERENCES, THE PHYSICIAN SAID THAT THEY KNEW ABOUT THIS CONCEPT, BUT THEIR TOLERANCE WAS APPROXIMATIVELY +4 ON CERELINK. HE SAYS HE WILL BE TAKING NOTE OF EVD VS CERELINK READING TO COMPARE IF A NEXT EVENT OCCURS. ADDITIONAL INFORMATION: WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: "YES". IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: "PHILIPS MONITOR MX800 REVISION M". WAS THE PATIENT LEAD ALWAYS CONNECTED: "YES ACCORDING TO NURSING TEAM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719480 ↗
• InjuryJul 18, 2025Output Problem; Output Problem

  1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00190. A FACILITY REPORTED THAT TWO CERELINK SENSORS (ID 826850) SHOWED AN ERROR MESSAGE IN THE MONITOR MENTIONING CABLE FAILURE. ON (B)(6) 2025, CERELINK SENSOR #1 WAS IMPLANTED. NURSING DOCUMENTATION REPORTS SENSOR IS NOT FUNCTIONAL AND SO THE PATIENT TRANSFERS TO ICU WITHOUT ICP MONITOR. ON (B)(6) 2025, THE PATIENT UNDERGOES A SECOND PROCEDURE TO IMPLANT "MICROSENSOR #2", SENSOR IS WORKING AFTER IMPLANTATION. ON (B)(6) 2025, THE PATIENT COMES BACK FROM MRI AND ERROR MESSAGE APPEARS ON THE MONITOR "SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR". AFTER REPLACING THE EXTENSION CABLE, THEY HAD THE SAME ERROR MESSAGE. NOTE: DURING FIELD VISIT ON (B)(6) 2025, I. T. V. (NURSE COUNSELOR) MENTIONS THAT THE SENSOR WAS NOT COILED IN LOOPS ON A DRY GAUZE ON PATIENT'S HEAD AS IFU DEMANDS FOR MRI. SHE SAYS SHE SAW A PART OF THE CENSOR'S WIRE HANGING STRAIGHT, AND THE OTHER PART WAS COILED IN LOOPS ON A DRY GAUZE ON PATIENT'S HEAD. ON (B)(6) 2025, DR. (B)(6) REPORTS THAT 2 SENSORS HAD PROBLEMS WORKING CORRECTLY AND THAT THE ERROR MESSAGE ON THE MONITOR MENTIONS CABLE FAILURE. MEDICAL STAFF CONNECTED THE PATIEN

  Patient problems: Insufficient Information

  MAUDE report 22546089 ↗
• InjuryJul 18, 2025Output Problem; Output Problem

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00187. A FACILITY REPORTED THAT TWO CERELINK SENSORS (ID 826850) SHOWED AN ERROR MESSAGE IN THE MONITOR MENTIONING CABLE FAILURE. ON (B)(6) 2025, CERELINK SENSOR #1 WAS IMPLANTED. NURSING DOCUMENTATION REPORTS SENSOR IS NOT FUNCTIONAL AND SO THE PATIENT TRANSFERS TO ICU WITHOUT ICP MONITOR. ON (B)(6) 2025, THE PATIENT UNDERGOES A SECOND PROCEDURE TO IMPLANT "MICROSENSOR #2", SENSOR IS WORKING AFTER IMPLANTATION. ON (B)(6) 2025, THE PATIENT COMES BACK FROM MRI AND ERROR MESSAGE APPEARS ON THE MONITOR "SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR". AFTER REPLACING THE EXTENSION CABLE, THEY HAD THE SAME ERROR MESSAGE. NOTE: DURING FIELD VISIT ON JUNE 6, 2025, I. T. V. (NURSE COUNSELOR) MENTIONS THAT THE SENSOR WAS NOT COILED IN LOOPS ON A DRY GAUZE ON PATIENT'S HEAD AS IFU DEMANDS FOR MRI. SHE SAYS SHE SAW A PART OF THE CENSOR'S WIRE HANGING STRAIGHT, AND THE OTHER PART WAS COILED IN LOOPS ON A DRY GAUZE ON PATIENT'S HEAD. ON JUNE 26, 2025, DR. (B)(6) REPORTS THAT 2 SENSORS HAD PROBLEMS WORKING CORRECTLY AND THAT THE ERROR MESSAGE ON THE MONITOR MENTIONS CABLE FAILURE. MEDICAL STAFF CONNECTED THE PAT

  Patient problems: Insufficient Information

  MAUDE report 22546085 ↗
• InjuryJul 10, 2025Incorrect Measurement; Incorrect Measurement

  1 OF 6 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2025-00165; 3013886523-2025-00166; 3013886523-2025-00167; 3013886523-2025-00168; 3013886523-2025-00169. THIS REPORT IS FOR THE 1ST EVENT (CERELINK ICP PROBE). A PHYSICIAN EXPRESSED A LOSS OF CONFIDENCE IN CERELINK ICP SENSORS. THEY ESTIMATE THAT IN 50% OF THE CASES WHERE A PATIENT HAD AN CERELINK ICP SENSOR AND A CHECK OF ICP WITH A FFT (FLUID FILLED TRANSDUCER) VIA THE EXTERNAL DRAINAGE SYSTEM THEY NOTICED A DECLINE AND DIFFERENCE THAT BECOMES BIGGER AND BIGGER (CFR DRIFT) AFTER A COUPLE OF DAYS. THEY DOUBLE CHECK THE FFT MEASUREMENT AS THIS IS POSITIONING (HIGHT) DEPENDANT, HOWEVER DON'T NOTICE MISTAKES WITH EVD SYSTEM, SO THEY CONCLUDED WRONG MEASUREMENT OF CERLINK SENSOR (USE THIS TOGETHER WITH DIRECTLINK). ADDITIONAL INFORMATION RECEIVED: - IS IT POSSIBLE TO KNOW HOW MANY TIMES THIS TYPE OF DYSFUNCTION WAS OBSERVED? IF YES, HOW MANY AND APPROXIMATE DATE? ANSWER: THEY ESTIMATE 50% OF THE CASE, AND AS I COUNT 38 PROBES SINCE 2023. I BELIEVE 18 WOULD BE AN EDUCATED ESTIMATION. - FOR EACH CASE, DID THEY REMOVE THE SENSOR? HOW DID THEY FOLLOW THE MONITORING? ANSWER: THEY NOTICED THE INCONSISTENCY AS THEY SIMULTANEOUSLY MEASURED I

  Patient problems: Insufficient Information

  MAUDE report 22472347 ↗
• InjuryJul 10, 2025Incorrect Measurement; Incorrect Measurement

  4 OF 6 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2025-00164, 3013886523-2025-00165, 3013886523-2025-00166, 3013886523-2025-00168, 3013886523-2025-00169. THIS REPORT IS FOR THE CERELINK ICP PROBE AS THE CUSTOMER INDICATED THE EVENT OCCURRED SEVERAL TIMES. A PHYSICIAN EXPRESSED A LOSS OF CONFIDENCE IN CERELINK ICP SENSORS. THEY ESTIMATE THAT IN 50% OF THE CASES WHERE A PATIENT HAD AN CERELINK ICP SENSOR AND A CHECK OF ICP WITH A FFT (FLUID FILLED TRANSDUCER) VIA THE EXTERNAL DRAINAGE SYSTEM THEY NOTICED A DECLINE AND DIFFERENCE THAT BECOMES BIGGER AND BIGGER (CFR DRIFT) AFTER A COUPLE OF DAYS. THEY DOUBLE CHECK THE FFT MEASUREMENT AS THIS IS POSITIONING (HIGHT) DEPENDANT, HOWEVER DON'T NOTICE MISTAKES WITH EVD SYSTEM, SO THEY CONCLUDED WRONG MEASUREMENT OF CERLINK SENSOR (USE THIS TOGETHER WITH DIRECTLINK). ADDITIONAL INFORMATION RECEIVED: IS IT POSSIBLE TO KNOW HOW MANY TIMES THIS TYPE OF DYSFUNCTION WAS OBSERVED? IF YES, HOW MANY AND APPROXIMATE DATE? ANSWER: THEY ESTIMATE50% OF THE CASE, AND AS I COUNT 38 PROBES SINCE 2023. I BELIEVE18 WOULD BE AN EDUCATED ESTIMATION. FOR EACH CASE, DID THEY REMOVE THE SENSOR? HOW DID THEY FOLLOW THE MONITORING? ANSWER: THEY NOTICED THE INCONS

  Patient problems: Insufficient Information

  MAUDE report 22472341 ↗
• InjuryMay 22, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A FACILITY REPORTED A NURSE WAS PREPARING TO SYNCHRONIZE CERELINK TO BEDSIDE MONITOR AND ACCIDENTALLY ZEROED THE ICP SENSOR (WHILE IMPLANTED). THE SENSOR WAS PLACED ON (B)(6) 2025, AND REMOVED ON (B)(6) 2025. THERE WERE NO COMPLICATIONS REPORTED FOR THE PATIENT. ADDITIONAL INFORMATION: MONITOR USED - CLK2116186 CABLE USED - 826845 SENSOR IMPLANT LOCATION: PARENCHYMA WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: PHILLIPS INTELLIVUE WAS THE PATIENT LEAD ALWAYS CONNECTED: YES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072376 ↗
• InjuryMay 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID: 826850) WAS IMPLANTED ON (B)(6) 2025. WHILE PREPARING THE PATIENT FOR TRANSPORT TO COMPUTED TOMOGRAPHY (CT) SCAN, THE BEDSIDE MONITOR PRESSURE BOX WAS MOVED TO THE TRANSPORT MONITOR, AND STAFF WERE UNABLE TO GET THE TRANSPORT MONITOR TO SYNCHRONIZE WITH THE CERELINK MONITOR. WHILE THE NURSE WAS TROUBLESHOOTING, THE PATIENT¿S ICP DRIFTED DOWN FROM THE MID-TEENS TO 0¿1. THEY CHANGED THE CERELINK MONITOR, BUT THE ICP REMAINED UNCHANGED. THEY THEN PLACED THE BEDSIDE MONITOR PRESSURE MODULE BACK INTO THE BEDSIDE MONITOR BUT AGAIN WERE NOT ABLE TO SYNCHRONIZE WITH THE CERELINK. THE ICP REMAINED AT 0¿1, AND THEY DECIDED TO ZERO THE SENSOR (WHICH WAS DONE PER THE TIME/DATE ON THE CERELINK MONITOR). ALTHOUGH THEY SUCCESSFULLY SYNCHRONIZED THE CERELINK TO THE BEDSIDE MONITOR, THEY DID NOT WAIT FOR THE BEDSIDE MONITOR¿S DIGITAL READOUT TO MATCH THE REFERENCE NUMBER SENT FROM THE CERELINK. THE ICP WAS STILL READING 0¿1, BUT WHEN THE PATIENT WAS STIMULATED OR COUGHED, THE ICP INCREASED TO AROUND 6, AND THE ICP WAVEFORM APPEARED NORMAL. IT WAS CONFIRMED THAT THE REFERENCE LEAD WAS SECURELY ATTACHED AND THAT THE SENSOR HAD BEEN RE-ZEROED. THE PATIENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069411 ↗
• MalfunctionMay 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A MICROSENSOR (ID 826850) WAS IMPLANTED ON (B)(6) 2025 IN A 12 YEAR OLD MALE ADMITTED FOR INTRACTABLE HEADACHES. ICP VALUES 8-9MMHG AND APPROPRIATE WAVEFORM. THERE WAS A WAVEFORM THE ENTIRETY OF THE IMPLANTATION. ONE HOUR AFTER INSERTION ICP VALUES TRENDING NEGATIVE. IT IS NOT KNOWN IF PATIENT LEAD WAS CONNECTED AT TIME OF INSERTION. PATIENT LEAD WAS CONFIRMED CONNECTED ON (B)(6) 2025. ICP VALUES MAINTAINED NEGATIVE MMHG READINGS THROUGHOUT THE DAY ((B)(6) 2025). PATIENT SITTING UP: -10 TO -13MMHG. PATIENT AT 30-45 HOB -2 TO -1MMHG. PATIENT FLAT ICP VALUES 3-4MMHG. PATIENT HAD GENERALIZED HEADACHE, HOWEVER NO NEW DEFICITS WITH NEGATIVE READINGS. MONITOR AND CABLE WERE REPLACED AND NEGATIVE READINGS PERSISTED. MRI OF BRAIN WAS COMPLETED PRIOR TO INSERTION ((B)(6) 2025), SHOWING NORMAL VENTRICLES OF THE BRAIN. PATIENT HAS VENTRICULOPERITONEAL SHUNT PLACED AS INFANT AND HAS NOT HAD REVISION DURING LIFETIME. TECHNOLOGY SURROUNDING CERELINK ICP MONITOR AND MICROSENSOR: IPHONE (WITHIN 1 FOOT), VIDEO GAME CONSOLE WITHIN 3 FEET, IV PUMP, PHILLIPS BEDSIDE MONITOR.

  Patient problems: Insufficient Information

  MAUDE report 22012752 ↗
• MalfunctionMay 13, 2025Failure to Zero; Failure to Zero

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008878 ↗