MAUDE Adverse Event Report: SOPHYSA SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS.; SM8

Model Number	SM8
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in china received a sophy sm8 valve implant in (b)(6) 2020 following an ich and open-skull surgery.Two weeks after the procedure, in early september, the patient's doctor suspected valve over drainage.The valve's release pressure was initially set to 110 mmh2o and was then adjusted to 140mmh2o.However, two weeks after this first adjustment, the doctor observed that the release pressure remained too low and re-adjusted it to 200mmh2o on (b)(6) 2024.Despite this adjustment, a pressure measurement test conducted by the hospital on (b)(6) 2024, indicated that the actual pressure was only 170mmh2o.The over drainage is not resolved and the low pressure has potentially caused severe neural damage.Currently the valve remains implanted in the patient.
Additional Manufacturer Narrative
The product is still implanted in the patient; therefore, we cannot conduct any investigation on it to understand the deprogramming.Moreover, it is impossible to perform a traceability analysis of the product because the batch number was not provided to us.Based on communications with the surgeon who performed the procedure, we confirmed that there was no control of the settings.In conclusion, we suspect misuse of the adjustment kit, not a valve deprogramming issue.This report is being resubmitted because the previous report sent on 11/22/2024 was not accepted (due to an incorrect follow-up number).
Event or Problem Description
A patient in china received a sophy sm8 valve implant in (b)(6) 2020 following an ich and open-skull surgery.Two weeks after the procedure, in early september, the patient's doctor suspected valve overdrainage.The valve's release pressure was initially set to 110 mmh2o and was then adjusted to 140mmh2o.However, two weeks after this first adjustment, the doctor observed that the release pressure remained too low and re-adjusted it to 200mmh2o on (b)(6) 2024.Despite this adjustment, a pressure measurement test conducted by the hospital on (b)(6) 2024, indicated that the actual pressure was only 170mmh2o.The overdrainage is not resolved and the low pressure has potentially caused severe neural damage.Currently the valve remains implanted in the patient.

• Brand Name: SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS.
• Common Device Name: SM8
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: lucie dubois ; rue sophie germain; besançon, 25000 ; FR 25000
• MDR Report Key: 20566303
• Report Number: 3001587388-2024-24366
• Device Sequence Number: 15410860
• Product Code: JXG
• UDI-Device Identifier: 03760124131093
• UDI-Public: 03760124131093
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: SM8
• Device Catalogue Number: SM8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 04/08/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female