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

Model Number	826828
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
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
2 of 2 reports.Other mfg report number: 3013886523-2022-00135.A facility reported a directlink icp module was showing negative readings after implantation.The sensor was replaced and one hour surgical delay was reported because when the sensor was replaced, the negative readings persisted; therefore, the sensors were not the cause.The monitoring continued with a competitor module available.
Additional Manufacturer Narrative
The directlink icp module was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - directlink module 823828 was tested according to procedure applicable, and no product problem was identified.Root cause - the root cause of the issue reported by customer could not be determined as the device worked correctly.
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: 14021219
• Report Number: 3013886523-2022-00136
• Device Sequence Number: 19481883
• Product Code: GWM
• UDI-Device Identifier: 10381780515784
• UDI-Public: (01)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): 07/07/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Male