MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823832
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Speech Disorder (4415); Partial Hearing Loss (4472); Decreased Appetite (4569)
Date of Event	09/16/2025
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 hakim valve (id 823832) was implanted in (b)(6) 2025.In (b)(6) 2025, the patient began experiencing discomfort, initially presenting with loss of appetite, followed by speech difficulties.On (b)(6) 2025, computed tomography (ct) scan revealed ventricular dilation.A subsequent examination identified an issue with the valve pressure adjustment: although it was set to 200, the display consistently showed 30.On (b)(6) 2025, the hakim valve was replaced with the same model.The patient is currently in good condition.
Additional Manufacturer Narrative
Updated fields: g3, g6, h11.Root cause analysis update - the programming issue reported by the customer could not be confirmed as the valve was program tested pass, the possible root cause could be due to biologicals debris, as mentioned in the ifu, accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting.The root cause for the pressure issue noticed during investigation is due to biologicals debris found in the plate and the cam.As mentioned in the ifu, accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 7396741 conform to specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 30 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, leak, reflux and siphon guard.The valve was then pressure tested but failed the test.The valve was dismantled and examined under microscope at appropriate magnification.Biological debris was noted on the cam and the plate.Root cause analysis - the root cause for the pressure issue noticed during investigation is due to biologicals debris found in the plate and the cam.As mentioned in the instruction for use (ifu), accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.The programming issue reported by the customer could not be confirmed as the valve was program tested pass, the possible root cause could be due to biologicals debris, as mentioned in the instruction for use (ifu), accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit, and impair the anti-reflux function.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h3, h11.Additional information: the patient is not in good condition with symptoms of hearing loss from time to time now.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h11.Corrected field: d6a.Additional information: "the initial implant date should be (b)(6) 2025 instead of (b)(6) 2025.¿.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23199752
• Report Number: 3013886523-2025-00268
• Device Sequence Number: 9159453
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)290331(10)7396741
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2026

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 Catalogue Number: 823832
• Device Lot Number: 7396741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 12/11/2025; 02/03/2026; 03/05/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/02/2026; 02/20/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian