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

Catalog Number	826828
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
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
5 of 12 reports (different patients, same failure).Other mfg report numbers: 3013886523-2024-00228; 3013886523-2024-00229; 3013886523-2024-00230; 3013886523-2024-00231; 3013886523-2024-00233; 3013886523-2024-00234; 3013886523-2024-00235; 3013886523-2024-00236; 3013886523-2024-00237; 3013886523-2024-00238; 3013886523-2024-00239.Case 3: a facility reported a directlink module (id 826828) with inconsistent values.The module was used with cerelink sensor (id 826851).The sensor was explanted.Consequence for the patient: over sedation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Directlink module was returned for evaluation: dhr - lot 179944 sn 16dlk13819, 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 according to procedures: 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.

• 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: 19950093
• Report Number: 3013886523-2024-00232
• Device Sequence Number: 18384299
• Product Code: GWM
• UDI-Device Identifier: 10886704078661
• UDI-Public: (01)10886704078661(10)179944
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown