MAUDE Adverse Event Report: SOPHYSA SOPHY® SM8 KIT PREATTACHED; SOPHY® SM8A KIT PREATTACHED / BO19-10

Model Number	SM8A-2010
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After the mri exam, the patient began to have health problems such as symptoms of hydrocephalus and severe disorders.The doctor observed that the valve was deprogrammed and had caused hyperdrainage.The doctor tried to adjust the valve, but the ideal adjustment was no longer achievable, either leading to overdrainage or dilated ventricles.The doctor decided to explant the valve and replace it with another one.Date of implatantion: (b)(6) 2024.Date of first mri exam: (b)(6) 2024.Date of explantation: (b)(6) 2024.
Additional Manufacturer Narrative
After submitting the initial report, we obtained additional information from the complainant and about the incident.The valve was implanted on (b)(6) 2024 at 110mmh2o.After an mri, on (b)(6) 2024, it was found that the valve had been deprogrammed and was at 200mmh2o.It was then reprogrammed to 110mmh2o as per the initial programming.On (b)(6) 2024, the patient presented with severe hydrocephalus with a change in her clinical condition and not related to the mri examination.Reprogramming to 140mmh2o was requested.On (b)(6) 2024 it was reprogrammed to 170mmh2o and later reprogrammed to 140mmh2o on (b)(6) 2024.Finally, the valve was explanted after several adjustments because it was not possible to regulate the pressure between two values.The adjustment at 140 mmh2o resulted in overdrainage, while the adjustment at 170 mmh2o caused dilation.The pressure range of the sm8a-2010 was not suitable for the patient's hydrocephalus profile, and the surgeon decided to explant and replace it.Our quality department conducted various analyses on the returned device: visual inspection : the valve with its preconnected reservoir and a part of preconnected distal catheter was returned quite clean, immersed in sterile water.The valve was set to position p8 (200 mmh2o).Organic residues were observed inside the valve chamber and on the spring.Pressure testing: the valve was compliant.Programming control: the valve was compliant.The batch file has been reviewed and the valve complies with the expected specifications when release from production.The valve complied with its specifications.Regarding accidental setting change during mri, in the instructions for use, it is required to check the position through x-ray or using the dedicated reading kit after each exposure to strong magnetic field and proceed with a new programming to the initial position.In conclusion, according to the additional information, the explantation of the valve was due to the specific needs of the patient and not related to the device.This report is being resubmitted because the previous report sent on 04/24/25 (increment 00021) was not accepted.
Event or Problem Description
After the mri exam, the patient began to have health problems such as symptoms of hydrocephalus and severe disorders.The doctor observed that the valve was deprogrammed and had caused hyperdrainage.The doctor tried to adjust the valve, but the ideal adjustment was no longer achievable, either leading to overdrainage or dilated ventricles.The doctor decided to explant the valve and replace it with another one.Date of implatantion: (b)(6) 2024, date of first mri exam: (b)(6) 2024, date of explantation: (b)(6) 2024.

• Brand Name: SOPHY® SM8 KIT PREATTACHED
• Common Device Name: SOPHY® SM8A KIT PREATTACHED / BO19-10
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21371940
• Report Number: 3001587388-2025-25052
• Device Sequence Number: 8598705
• Product Code: JXG
• UDI-Device Identifier: 03760124131222
• UDI-Public: (01)03760124131222(11)230307(17)280101
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: SM8A-2010
• Device Catalogue Number: SM8A-2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: Required Intervention
• Patient Sex: Female