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

Catalog Number	826828
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
Linked to mfg report numbers: 3013886523-2024-00009; 3013886523-2024-00010; 3013886523-2024-00017; 3013886523-2024-00011.A facility reported: "yesterday at 7:00 am i replaced the icp meter because the black box showed a red light.When connecting the same catheter (sensor) to another box, the icp could not be replaced." "replaced again at 11:00 pm because the catheter (sensor) did not work.When i switched from the black box to the monitor, the monitor indicated that the icp meter was defective, so it was replaced again." "last night at 1:30 am the monitor indicated that the catheter (sensor) was defective and that it had to be replaced.I changed the caterers (sensor) again." "last night at 03:00 am it stopped working and i didn't do anything anymore, but this morning when i plugged it in it worked again.".
Additional Manufacturer Narrative
Directlink module was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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.
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: 18619284
• Report Number: 3013886523-2024-00016
• Device Sequence Number: 18012160
• 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): 07/12/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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 Sex: Unknown