MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Model Number	826850
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a patient had icp readings as low as -10 from a cerelink microsensor; patient received icp monitor for headaches of unknown etiology.Account manager and clinical specialist were both present for insertion, which went very well.Patient had icp value in the normal range of 4 ¿ 6.Patient was disconnected prior to transfer to bed from the or table.Patient was reconnected once in pacu.Readings were stable in the 4-6mmhg.Instructed pacu rns to disconnect patient for transport to the icu.Icp value was 2 at time of disconnection, later values were -3.Bedside rn said patient was clinically intact.
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.
Additional Manufacturer Narrative
Updated fields: d1, d4, d6a, d9, h2, h3, h10.Additional information received on 04/19/2022 indicates the following: the complaint is probably against cerelink sensor, but customer is unsure.They believe the device was explanted the following day or two, but unknown for certain.There were no clinical signs, symptoms or reasons to verify the negative reading.Lot or serial number is unknown.
Additional Manufacturer Narrative
Cerelink sensor was not returned for evaluation (as per customer, product not available); and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.A corrective and preventive action (capa) was opened to investigate the failure mode "out of range reading".

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13863937
• Report Number: 3013886523-2022-00108
• Device Sequence Number: 12105236
• Product Code: GWM
• UDI-Device Identifier: 10886704075448
• UDI-Public: 10886704075448
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 826850
• Device Catalogue Number: 826850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 07/05/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/29/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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