CERELINK ICP MONITOR
Report
- Report Number
- 3014334038-2024-00186
- Event Type
- Death
- Date Received
- September 9, 2024
- Date of Event
- August 19, 2024
- Report Date
- June 26, 2025
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- GWM
- UDI-DI
- 10381780533788
- PMA / PMN Number
- K183406
- Removal / Correction Number
- 3014334038 -8/23/2022-00
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE CERELINK MONITOR WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ROOT CAUSE UPDATE: WITHOUT THE DEVICE RETURN AND THE ABILITY TO ANALYZE THE WAVEFORM, TREND AND DEBUG DATA, THE ABILITY TO REVIEW HOSPITAL RECORDS, OPERATIVE, FOLLOW UP NOTES, ETC., THE ROOT CAUSE CANNOT BE DETERMINED. WE NONETHELESS HEREAFTER ATTEMPT TO MAKE AN ASSESSMENT OF POTENTIAL CAUSES BASED ON THE INFORMATION WE HAVE. THE ALLEGATION OF DEVICE MALFUNCTION CAUSAL TO PATIENT DEMISE FROM AN INACCURATE STATIC READING APPROXIMATELY 15 TO 16 DAYS STATUS POST-IMPLANTATION IS UNSUBSTANTIATED AND HIGHLY UNLIKELY AS THE SENSOR APPARENTLY FUNCTIONED RELIABLY THROUGH DAY 14. NO ELEMENT SUPPORTS A CONCLUSION THAT THE MEDICAL DEVICE FAILED. ON THE CONTRARY, THE INFORMATION AVAILABLE INDICATES THAT THE DEVICE FUNCTIONED APPROPRIATELY: (1) CERELINK WAS NOT REVIEWED, SO NO CONCLUSION CAN BE DRAWN REGARDING A MALFUNCTION; (2) THE DEVICE FUNCTIONED RELIABLY THROUGH DAY 14, CONSISTENT WITH EXPECTED PERFORMANCE AND KNOWN LIMITATIONS OF STRAIN GAUGE SENSORS IN VIVO; AND (3) THE MOST LIKELY EXPLANATION FOR THE ABSENCE OF ELEVATED ICP READINGS IS A BIOLOGICAL RESPONSE SUCH AS ENCAPSULATION. THIS IS PRECISELY WHY PROTOCOLS ADVOCATE FOR MULTIMODAL NEUROMONITORING, TO ENSURE THAT FOREIGN BODY REACTIONS DO NOT COMPROMISE DATA INTERPRETATION AND TO SUPPORT CLINICAL DECISION-MAKING BEYOND THE RECOMMENDED MONITORING PERIOD.
2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00272. A FACILITY REPORTED: "SENSOR IMPLANTED ON (B)(6) DURING THE NIGHT 18-19 AUGUST, INTRA-VENTRICULAR PRESSURE OF PATIENT INCREASE SUDDENLY BUT THE VALUE OF ICP READ ON CERELINK MONITOR AND ON PATIENT MONITOR DID NOT MOVE, IT WAS STABLE. SENSOR EXPLANTED ON 19 AUGUST.". - CLINICAL CONSEQUENCE: "BRAIN INVOLVEMENT". - "THEY MONITOR ALTERNATIVELY THE INTRA-VENTRICULAR PRESSURE". - HOW DID YOU DETECT THAT INTRA-VENTRICULAR PRESSURE OF PATIENT INCREASE? "BILATERAL MYDRIASIS". - DID THE INCIDENT INCREASE THE PATIENT'S CARE TIME ? "THE INCIDENT IS RESPONSIBLE FOR THE PATIENT'S DEATH". ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538461 | CERELINK ICP MONITOR | ICP MONITOR-CERELINK | GWM | INTEGRA LIFESCIENCES MANSFIELD | 10381780533788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |