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)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
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
1 of 3 reports.Other mfg report numbers: 3013886523-2024-00065 3013886523-2024-00066.A facility reported a patient was hospitalized due to traumatic brain injury for approximately one to an half weeks, decompressed bilaterally.Intracranial pressure measurements with intraparenchymal sensor and direct link were unreliable values (too high/too low).Therefore, the system was replaced with intraventricular sensor but the problem remained.The first sensor was implanted on (b)(6) 2024; explanted on (b)(6) 2024.Second sensor implanted on (b)(6) 2024; explanted (b)(6) 2024.Medical staff continued with not invasive monitoring (tcd diastolic flow velocity and optic nerve sheat).
Additional Manufacturer Narrative
The directlink module was returned for evaluation: dhr - lot cvjbn3, conformed to the specifications when released to stock 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.Root cause - no exact root cause could be determined as the technician could not confirm any problem with the device at the time of investigation.
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 08540 ; 6099362319
• MDR Report Key: 18838246
• Report Number: 3013886523-2024-00064
• Device Sequence Number: 7415596
• Product Code: GWM
• UDI-Device Identifier: 10886704078661
• UDI-Public: (01)10886704078661(10)CVJBN3
• 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): 06/16/2024

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 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: 02/14/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2016
• 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