MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PRG CYL INTEGRAT CONNECTOR; HYDROCEPHALUS

Model Number	NS5034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2022
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 a patient had a peritoneal valve (id ns5034) implanted on (b)(6) 2020.Mri showed total resolution of pericerebral effusion so they decided to change the flow of the valve slowly: on (b)(6) 2022 it was 70 mmh2o / on (b)(6) 2022 it was 80 mmh2o.On (b)(6) 2022 they wanted 90 mmh2o but the valve was blocked at 80 mmh2o.Medical staff decided to do a revision on (b)(6) 2022.The valve was broken.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The valve was returned for evaluation: dhr - no anomalies occurred during the manufacturing process.Failure analysis - the valve was visually inspected; no defects were noted.The valve was tested for programming, the valve failed the test.The valve passed the tests for occlusion, leaks and reflux.The silicone was cut just after the valve casing and the cam mechanism was gently moved.The valve was retested for programming, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: the cam magnets were controlled and failed.Root cause - the root cause for the issue reported by the customer is due to the abnormal polarization of the cam magnets or due to biological debris and protein build up interfering with the valve, at the time of investigation biological debris were noted.The root cause for the abnormal polarization noted during the investigation, was probably caused by an exposition of a too strong magnetic field, as noted in the ifu, ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.
Event or Problem Description
N/a.

• Brand Name: PRG CYL INTEGRAT CONNECTOR
• Common Device Name: HYDROCEPHALUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15928159
• Report Number: 3014334038-2022-00277
• Device Sequence Number: 19932759
• Product Code: JXG
• UDI-Device Identifier: 10886704046653
• UDI-Public: 10886704046653
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Expiration Date: 10/31/2024
• Device Model Number: NS5034
• Device Catalogue Number: NS5034
• Device Lot Number: J63P86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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 Age: 4 YR
• Patient Sex: Female
• Patient Weight: 23 KG