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

Catalog Number	826828
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Directlink module was not returned for evaluation (as per customer, product not available) 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, however, the possible root cause for this issue reported by the customer could be due to failure of the probe detection mechanism, or the possible root cause could be linked to cerelink sensors used with this module.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
2 of 3 reports.Other mfg report numbers: 3013886523-2024-00039 3013886523-2024-00041.A facility reported a cerelink sensor (b)(6) had very high pressure (300), and then a flat line was seen five hours after placement.The sensor was removed and replaced.The second sensor worked for 11 hours, then suddenly, flat line.It was explanted and monitoring stopped.The sensors were connected to directlink module (id 826828).

• 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: 18697903
• Report Number: 3013886523-2024-00040
• Device Sequence Number: 20614769
• 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
• Report Date (Section B): 02/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/13/2024
• 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