MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV W RICKHAM UNITIZED

Catalog Number	823113
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	08/30/2025
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 1-year-old infant who had hakim valve implanted on (b)(6), 2024 due to pediatric hydrocephalus."on an unknown date, shunt pressure got re-adjusted twice later implantation, but now pressure was not get adjusted, doctor tried to adjust number of times from past 4 days with different timings and also with the different programmers, presented with raised ict complaints (intracranial pressure increased).Doctor attempted to reduce the pressure tried with different programmers but unable to set the pressure, notch is not moving confirmed on x-ray and suspecting shunt malfunction.Neurosurgeon claims it may be a shunt malfunction." additional information received: events onset date - september 1, 2025.Valve was removed and replaced on (b)(6) 2025.Did the patient had any signs and symptoms due to the product problem? "patient felt drowsiness " current status of the patient: "doing good.".
Additional Manufacturer Narrative
Updated fields: b3, d9, g3, g6, h2, h3, h11.Additional information: medical history: pediatric hydrocephalus.Onset date of the event: 30/08/2025.Any clinical event due to suspect device or not: no.Hospitalization details: patient got admitted on (b)(6) and went for the shunt revision surgery on (b)(6) and got discharged on (b)(6).Seriousness criteria "disability/permanant damage": no disability/permanent damage, shunt malfunction got identified on right time and revision has done on immediately.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823113) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the valve mechanism, as mentioned in the adverse event section of 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".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: MICRO CHPV W RICKHAM UNITIZED
• Common Device Name: CHPV
• 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: 23199753
• Report Number: 3013886523-2025-00266
• Device Sequence Number: 9159454
• Product Code: JXG
• UDI-Device Identifier: 10381780534501
• UDI-Public: (01)10381780534501(17)290531(10)7406265
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2025

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: 823113
• Device Lot Number: 7406265
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 11/07/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/31/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: 12 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian