MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN ICP MONITOR; ICP EXPRESS - MONITOR

Catalog Number	XXX-ICP EXPRESS MONITOR
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2023-00330.A facility reported a cerelink sensor (id (b)(6)) was implanted on (b)(6), 2023.The icp mean decreased and started reading negative approximately 2 hours 20 minutes post insertion.In the operating room per the outpatient note, when the sensor was placed, the opening pressure was 19 at approximately 1330, after the ventricular catheter was replaced, the icp dropped to 11.The patient & monitor were transported to the post anesthesia care unit (just down the hall) during transportation, the icp monitor died.Prior to this the icp monitor had been plugged in.After being plugged in (in pacu) the icp monitor showed an icp of 3 at approximately 1410.The icp monitor was requesting "zero to patient monitor".The monitors in the pacu do not have the capability to monitor icps.At that point, the patient was taken to the pediatric intensive care unit where the icp monitor read 2-3 at -1448.There had been an unsuccessful attempt to "zero" to the patient monitor.The interface cable was disconnected from the patient monitor, then reconnected, accepted the reference #500 as it was correct, zeroed to the patient monitor, pressed enter, calibrated to 100 and pressed enter.At that point, the icp on the icp monitor & the patient monitor matched, and the wave form was good.Negative pressures were displayed from approximately 1635 that same day and continued throughout the hospitalization stay until the transducer was removed.It appears that when the battery died, the icp monitor (id (b)(6)) lost its ability to read accurate pressures transmitted from the microsensor.Based on the additional information received, the medical staff believed that the monitor was to blame.The sensor was explanted on (b)(6), 2023.Cerelink questionnaire provided: - monitor used: icp express.- time/date of sensor implant: (b)(6) 2023 @ 1330 est.- time/date of failure: (b)(6) 2023@ 1635.- it appears that when the battery died, the icp monitor lost its ability to read accurate pressures transmitted from the microsensor.(b)(6) 2023 -3 to 0.(b)(6) 2023 -9 to 4.(b)(6) 2023 -6 to 4.(b)(6) 2023 -11 to 5.(b)(6) 2023 -11 to 6.(b)(6) 2023 -10 to 6.- kit used basic (b)(6).- serial number (located on backside of sensor) (b)(6).- lot number (located on the unit carton/box): unknown.- implant location: parenchymal.- hospital location of implant: operating room.- did the failure occur during patient movement? (i.E.Reposition, transport, out of bed for bathroom, ambulate, chair, etc.) after.- was a movement assistance device used? if yes, please specify.No.- amount of time between patient movement and failure event.Approximately 2 hours 20 minutes.- was the microsensor disconnected from the integra/codman icp monitor during each phase of transport? no.- did the patient receive an mri or ct scan before the failure occurred? no.- what was the mean icp before the ¿event¿ icp value: 2 to 3.- what was the icp waveform quality before the ¿event¿? (if connected to patient monitor) good.- what is the current mean icp? sensor discontinued (b)(6) 2023 - what is the icp waveform quality after the ¿event¿? good.- when the failure occurred, was the integra/codman icp monitor plugged into the wall? yes.- when the failure occurred, was the integra/codman icp monitor connected to a patient monitor? yes.A.If yes, provide patient monitor make & model: make: phillips / model: intellivue mx800.- does the icp value on the integra/codman icp monitor match the icp value on the patient monitor? it consistently matched.- when the failure occurred, where was the integra/codman icp monitor positioned? iv pole.- other devices implanted in the head? (shunt, evd, subdural drain).If yes, specify yes: vp shunt.- were bipolar or monopolar forceps used while the sensor was plugged in? no.- provide a description of any unusual events or issues that occurred during the implantation or during the patient care: none.- describe the quality of the insertion: routine.- if icp express was used, what did the display show at point of ¿event¿? icp value: -3 to 0.Systolic value: unknown, diastolic value:unknown.- was more than 1 integra/codman icp monitor used for the sensor? (example: 1 cerelink/icp express in or and different cerelink/icp express in icu): no.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The icp monitor (id (b)(4)) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis ¿ the complaint was confirmed.The unit had its battery replaced and also the lcd subassembly.Unit passed all operation and functional testing.Root cause analysis ¿ the root causes include line failure/current surge, blackout/brownout.The instruction for use (ifu) for this device provides guidance on how to extend and prolong the battery life of the icp express monitor, which is recommended for customers to observe and follow.

• Brand Name: UNKNOWN ICP MONITOR
• Common Device Name: ICP EXPRESS - MONITOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17781289
• Report Number: 3013886523-2023-00331
• Device Sequence Number: 5493011
• Product Code: GWM
• UDI-Device Identifier: 10886704042341
• UDI-Public: 10886704042341
• Combination Product (Y/N): N
• PMA/510(K) Number: K945585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: XXX-ICP EXPRESS MONITOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown