MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHY ADJUSTABLE VALVE

Device Problem Device Inoperable (1663)

Patient Problem Hydrocephalus (3272)

Event Type  malfunction  

Event Description

We were informed by one of our distributors that an sm8 valve had to be removed immediately after implantation.Our contact states that the valve was "not working at all", without giving any details regarding the incident or the context.We are currently trying to obtain further information regarding the event and the device involved, without success to this day.

• Brand Name: SOPHY
• Type of Device: SOPHY ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe audras ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 7421250
• MDR Text Key: 105519236
• Report Number: 3001587388-2018-18128
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention