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

Model Number	826828
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Other mfg report numbers: 3013886523-2022-00537, 3013886523-2022-00538, 3013886523-2022-00539, 3013886523-2022-00540, 3013886523-2022-00541.A facility reported the icp readings of a microsensor were stable 2-3 hours after implantation.But after that, the value kept drifting down until it was in the negative range at some point.4 cerelink icp sensor with metal skull pin set were implanted, 2 different directlink modules were used.All cables were swapped and different patient monitors connected.The error kept appearing.According to reported information, it is unknown if there was patient injury and it is also unknown if there was surgical delay.
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
Directlink module was not returned for evaluation 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.Based on the information reported by customer, the issue did not seem to be linked to the modules themselves.That's why the clinic decided to continue to use directlink modules, cables and it confirmed that the error had not occurred again.However, the possible root cause of the issue reported by customer could probably be due to damaging sensor.Additional information received: - all the device were implanted into 1 patient.- reference of phillips patient's monitor: mindray beneview variante t8 - consequences due to dysfunction : "this is self-explanatory.If the patient cannot be monitored or his intracranial pressure cannot be monitored, then he cannot be optimally cared for either, since valid measurement data on the constitution are missing." - underlying medical surgery : patient with a traumatic brain injury - outcome of patient : no feedback from the doctors.

• Brand Name: DIRECTLINK ICP MODULE
• Common Device Name: DIRECTLINK - MODULE
• 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: 15753542
• Report Number: 3013886523-2022-00542
• Device Sequence Number: 2868693
• 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
• Report Date (Section B): 02/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 826828
• Device Catalogue Number: 826828
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/15/2023
• 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