MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DIRECTLINK ICP MODULE; DIRECTLINK - MODULE

Model Number	826828
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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
2 of 2 reports.Other mfg report number: 3013886523-2022-00591.A facility reported a cerelink sensor was implanted, the values were stable for one day until suddenly dropped to negative numbers.The sensor and the directlink monitor were replaced.
Additional Manufacturer Narrative
Additional information received: "probe connected to directlink (module) and zeroed.Directlink connected to patient monitor in theatre.Probe shows pressure of 6 mmhg, which seems realistic.Patient is transferred to the ib.Adjustment of monitor and directlink with initial pressure of 6 mmhg, after 4-6 hours pressure drops into negative.Recalibration on the monitor and reproducible pressures measured.Later, negative pressures not only in sitting or standing position, but also in lying position, but when crying the pressure rises again as expected and then slowly drops again to negative for hours.Before explantation of the probe, another probe with a different directlink, we have 2 devices, zeroed and installed.Before explantation of the probe, another probe with a different directlink, we have 2 devices, zeroed and installed.Same behavior as with the first probe (pressure positive, then negative again).Due to the difficulties, no more use on this and other patients.Received a replacement device from the supplier.Test of the device with another probe, test intraoperatively for a few minutes with reproducible pressure of 17 mmhg.As it was not certain whether the difficulties were due to the directlink or the probes or the connection directlink to the patient monitor, this was to be tested this week in consultation with the supplier.Patient male of 5 years old.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 direclink module was returned for evaluation: dhr - the lot met specifications when released failure analysis - the module was cleaned with isopropyl alcohol 70% and visually inspected: no defect was noted.The module was inspected: no defect was noted.The complaint evaluation was unable to conclusively verify the complaint as valid.Device passed all testing.The root cause of the issue reported by customer could not be determined as the device worked correctly.

• Brand Name: DIRECTLINK ICP MODULE
• Common Device Name: DIRECTLINK - MODULE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16096243
• Report Number: 3013886523-2022-00592
• Device Sequence Number: 12401834
• Product Code: GWM
• UDI-Device Identifier: 10381780515784
• UDI-Public: 10381780515784
• Combination Product (Y/N): N
• PMA/510(K) Number: K152670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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 Model Number: 826828
• Device Catalogue Number: 826828
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 06/20/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/23/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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 Age: 5 YR
• Patient Sex: Male