MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRA NPH LOW FLOW VALVE

Catalog Number	909512
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Hydrocephalus (3272)
Date of Event	04/11/2023
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
A facility reported that the patient experienced a headache, and after examinations by the physicians, it was found that the nph low flow valve (909512) was not draining.The valve was implanted on (b)(6)2021 and worked perfectly for over a year, but it had to be replaced on (b)(6)2022 (reoperation), as it was not draining.The nature of the event was confirmed as hydrocephalus.The device was reported as lost at the facility, and will not be returned.
Additional Manufacturer Narrative
The integra nph low flow valve (909512) was not returned for evaluation: device history record (dhr) review - lot number information has been provided; therefore, device history record (dhr) was reviewed and showed that the lot conformed to the specifications when released to stock.Failure analysis - the device was lost at the hospital; therefore, a physical evaluation of the device could not be performed.However, a medical assessment was performed and concluded that ¿due to the loss of the product, insufficient evidence exists to confirm or suggest a casual relationship to the device." root cause - the possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve.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: INTEGRA NPH LOW FLOW VALVE
• Common Device Name: NPH LOW FLOW VALVE
• 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 ; 6099362319
• MDR Report Key: 17509090
• Report Number: 9612007-2023-00002
• Device Sequence Number: 6496368
• Product Code: JXG
• UDI-Device Identifier: 10381780033844
• UDI-Public: 10381780033844
• Combination Product (Y/N): N
• PMA/510(K) Number: K140722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2022
• Device Catalogue Number: 909512
• Device Lot Number: 0212472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/12/2023
• Date Device Manufactured: 01/25/2019
• 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