MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA CSF DRAINAGE SYSTEM W/PATIENT LINE ONE WAY VALVE; N/A

Catalog Number	10100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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
A facility reported that a part of the monitorr csf drainage system w/patient line one way valve (10100) that is intended to be fused became dislodged (next to the stopcock near the transducer), resulting in cerebrospinal fluid (csf) leakage.Additional information has been requested.
Additional Manufacturer Narrative
The monitorr csf drainage system w/patient line one way valve (10100) was not returned for evaluation after three good faith attempts (gfes) were made and no photos were provided to evaluate the reported ¿dislodgement.¿ however, investigation was performed with available information as follows: device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed, and no anomalies were found.Investigation findings - the complaint reported a ¿device failure next to the stopcock near the transducer¿; therefore, from the complaint description it seems that the pvc tubing broke off or got disconnected from the ¿manifold stopcock¿.Pvc clear tubing is attached to the stopcock by means of solvent bonding (also known as solvent welding) per local procedures and dhr instructions.Each assembly (100%) is leak tested during the product manufacturing process.As per complaint information the device was in use for eight (8) days (4/2/24 ¿ 4/10/24) prior to the reported disconnection.It is unknown what activities were taking place, if any, when the tubing got disconnected (e.G., transporting, moving, turning, etc.The patient) that could have contributed to the tubing disconnection.As per information provided in the complaint narrative, the customer is concerned because they report to ¿have placed ten (10) evds and have had three (3) of these failures¿.This 30% failure rate is not representative of the lot¿s (or product overall) behavior in the field since no other complaints have been received for lot 7287676.However, no further evaluation can be made since the unit has not been returned for evaluation and therefore, a root cause determination is not possible at this moment.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.

• Brand Name: CSF DRAINAGE SYSTEM W/PATIENT LINE ONE WAY VALVE
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19388607
• Report Number: 2648988-2024-00017
• Device Sequence Number: 20529773
• Product Code: JXG
• UDI-Device Identifier: 10381780070825
• UDI-Public: 10381780070825
• Combination Product (Y/N): N
• PMA/510(K) Number: K191684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 10100
• Device Lot Number: 7287676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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: Unknown