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

Catalog Number	826828
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 3 reports.Other mfg report numbers: 3013886523-2023-00361, 3013886523-2023-00362.A facility reported a multi trauma patient with a normal intracranial pressure (icp): after 5 minutes there was a fluctuation in icp line; high drift and negative drift.They did everything according the procedure, directlink was green, changed module , changed sensor several times.Sensor was in situ and checked the directlink: no signals like red or orange light, it was green.
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
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 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.Additional information received: "date of event unknown"."there were no consequences for the patient, except that we could not measure pressure, but the patient also had an evd (external ventricular drain) and with that you can also measure a kind of icp"."no delay in patient care"."patient has been discharged to the nursing department; current status unknown.Patient is an adult".
Event or Problem Description
N/a.

• 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: 17961382
• Report Number: 3013886523-2023-00360
• Device Sequence Number: 12082852
• Product Code: GWM
• UDI-Device Identifier: 10886704078661
• UDI-Public: 10886704078661
• 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): 11/16/2023

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: 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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