MAUDE Adverse Event Report: SOPHYSA POLARIS® ADJUSTABLE VALVE; POLARIS® SPV ADJUSTABLE VALVE

Model Number	SPV
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting product return to perform device investigation.
Event or Problem Description
An 86-year-old patient underwent ventriculoperitoneal shunting surgery on (b)(6) 2025, with the placement of a polaris 400 valve for hydrocephalus.The postoperative period was uneventful, with a marked improvement in walking and sphincter disorders.The patient returned for a consultation due to a recurrence of walking and sphincter disorders, without associated headache.A brain ct scan was then performed, revealing bilateral subdural hematomas with mass effect.The examination found that the valve was set at 70 mmh2o, whereas it had initially been set at 200 mmh2o postoperatively.The patient therefore underwent further surgery on (b)(6) 2025, with replacement of the valve.
Additional Manufacturer Narrative
Initial: awaiting product return to perform device investigation.Final: the valve complies with our specifications in terms of both pressure and programming.
Event or Problem Description
An 86-year-old patient underwent ventriculoperitoneal shunting surgery on (b)(6) 2025, with the placement of a polaris 400 valve for hydrocephalus.The postoperative period was uneventful, with a marked improvement in walking and sphincter disorders.The patient returned for a consultation due to a recurrence of walking and sphincter disorders, without associated headache.A brain ct scan was then performed, revealing bilateral subdural hematomas with mass effect.The examination found that the valve was set at 70 mmh2o, whereas it had initially been set at 200 mmh2o postoperatively.The patient therefore underwent further surgery on (b)(6) 2025, with replacement of the valve.

• Brand Name: POLARIS® ADJUSTABLE VALVE
• Common Device Name: POLARIS® SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• MDR Report Key: 23494678
• Report Number: 3001587388-2025-00114
• Device Sequence Number: 21049722
• Product Code: JXG
• UDI-Device Identifier: 03760124131253
• UDI-Public: (01)03760124131253(11)250402(17)300201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141227
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: SPV
• Device Catalogue Number: SPV
• Device Lot Number: F25040355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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: 86 YR
• Patient Sex: Male