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

Catalog Number	823164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve was implanted between (b)(6) 2024.On an unknown date, as per physician, the ct imaging showed squeezed ventricles (cerebral ventricle collapse), due to continuous over-drainage of csf (cerebrospinal fluid).The patient was hospitalized on (b)(6) 2024 with fever, increase blood pressure, seizure like activity, his physical conditions showed- glasgow coma scale e4vtm2 and had conservative treatment.Shunt pressure was set to 150.The patient's pressure settings were adjusted from 80 mm to 180 mm on different days, and the current shunt pressure was 180 mm h2ok (high).After several pressure-setting adjustments in the past few months/days, the condition of the patient did not improved, it was worsening, and the patient was bedridden.As per the physician, the shunt was not functioning.Despite the increased pressure, a sunken brain was still observed.Confirmative x-rays were taken before and after the programming.The final diagnosis was reported as an ftc-operated head injury with a programmable shunt in situ.The patient was discharged on (b)(6) 2024 in stable condition.Discharge medication was listed as: - taxim tablet 200 orally twice daily for 7 days, - tab pan 40 once daily (od) for 1 month-on empty stomach, - tab levera 500 (3-time day) (tds), - tab encorate 500 tds, - tab epsolin 100 tds, - tab amlodipine 5mg od, - tab dolo 650 sos (as needed)-for fever, - rtf (ready to feed) 300ml/3hrly.The patient was advised to consult in case of emergency and follow up consult after one week of discharge.The device was still implanted to the patient.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hakim valve (id 823164) was not returned for evaluation as the product remains implanted therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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.

• Brand Name: PROG VALVE INLINE
• 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: 22159957
• Report Number: 3013886523-2025-00128
• Device Sequence Number: 12581230
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: 10381780519249
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2025

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: 823164
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; DOLO; ENCORATE; EPSOLIN; LEVERA; TAXIM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male