MAUDE Adverse Event Report: SOPHYSA POLARIS OR SOPHY; ADJUSTABLE VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

The model of the valve is not clear.The device is not returned to the manufacturer.No further information available from user facility.Impossible to continue the incident investigation.The initial report was originally submitted in september 2016 the initial report is resubmitted in january 2020 as requested by the fda.The information provided in september 2016 has not been modified except: manufacturer contact email.Type of report (30 days).Conclusion code ( the number 71 no longer exists).Medwatch 3500a format which has been updated since 2016.

Event Description

In a (b)(6) hospital, it is said that 2 patient suffered from subdural hematoma that is suspected to be related to the implantation of the valve.The subdural hematoma caused death in the patient.

• Brand Name: POLARIS OR SOPHY
• Type of Device: ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; 91400 ; FR 91400
• Manufacturer Contact: viviane payrou ; 5 rue guy moquet; orsay 91400 ; FR 91400
• MDR Report Key: 5708753
• MDR Text Key: 241451911
• Report Number: 3001587388-2015-15451
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention