MAUDE Adverse Event Report: SOPHYSA POLARIS® SPV ADJUSTABLE VALVE / ANTECHAMBER

Model Number	SPVA
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: awaiting product return to perform a device analysis.
Event or Problem Description
20 days after intervention, the patient returned to the hospital with hydrocephalus symptoms.The surgeon controled the pressure twice and he realised that there was a variation of pressure going from 110 mmh20 to 150mmh20.He explanted the valve and implanted another one form medtronic.
Event or Problem Description
20 days after intervention, the patient returned to the hospital with hydrocephalus symptoms.The surgeon controled the pressure twice and he realised that there was a variation of pressure going from 110 mmh20 to 150mmh20.He explanted the valve and implanted another one from medtronic.
Additional Manufacturer Narrative
Initial: awaiting product return to perform a device analysis.Final: the reported defect could not be reproduced.At the state of return, no default was observed regarding the magnetic lock.The calibration drift that might have benne caused by a temporary obstruction due to organic residues appeared to be irreversible.

• Brand Name: POLARIS® SPV ADJUSTABLE VALVE / ANTECHAMBER
• Common Device Name: POLARIS® SPV ADJUSTABLE VALVE / ANTECHAMBER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 24277122
• Report Number: 3001587388-2026-00008
• Device Sequence Number: 9862007
• Product Code: JXG
• UDI-Device Identifier: 03760124131307
• UDI-Public: (01)03760124131307(11)250729(17)300701
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K1412227
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic