MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number	823100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/20/2025
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
It was reported a hakim valve (id 823100) had been implanted for a long time and the patient developed normal pressure hydrocephalus symptoms.An x-ray was taken and it was showing a "defect", therefore, the valve was removed and replaced.The patient recovered.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hakim valve was returned for evaluation: dhr - no discrepancies were noted.Failure analysis - the valve was visually inspected; the stator and the cam were dislodged.The valve could not be program tested as the cam was dislodged.The pressure test could not be performed as the valve was not program.The valve could not be flush and leak tested as the cam was dislodged.The valve was dismantled and was examined under microscope at appropriate magnification: marks and a bump from the pivot was noted on the casing.Root cause - the root cause for the issue reported by the costumer is due to the dislodged stator and cam.The root cause for the valve not program issue is due to the dislodged stator and cam.The root cause for the dislodged stator noted during the investigation is due to the valve receiving a hard knock.The root cause for the bump marks in the valve casing noted during the investigation is due to the valve receiving a hard knock.
Event or Problem Description
N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23322776
• Report Number: 3013886523-2025-00283
• Device Sequence Number: 16111615
• Product Code: JXG
• UDI-Device Identifier: 10381780534457
• UDI-Public: 10381780534457
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown