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

Catalog Number	823832
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Speech Disorder (4415)
Date of Event	10/15/2025
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 via ventriculoperitoneal (vp) shunt on (b)(6) 2025, with the pressure set to 180.After discharge, patient was transferred to rehabilitation hospital.The computed tomography (ct) scans reveal ventricular shrinkage and over-drainage by the shunt tube.The patient is conscious but with unclear speech, and the overall condition is stable.
Additional Manufacturer Narrative
Updated fields : d4, d8, d9, g6, h1, h2, h3, h4, h6, h11.The hakim programmable valve (823832) was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, a possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.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: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08540
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23498365
• Report Number: 3013886523-2025-00292
• Device Sequence Number: 12989520
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281130(10)7330013
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/02/2026

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: 7330013
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian