MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number SPVA-2010

Device Problem Device Inoperable (1663)

Patient Problem Hydrocephalus (3272)

Event Date 09/02/2016

Event Type  malfunction  

Event Description

The description of the event that we received is not very clear.Despite our many attempts to obtain more accurate information on the event, we could not get a clear answer from the user.The physician explains that the valve had to be removed because it could no longer be adjusted.However, he also explains that the patient suffered from an infection and that the valve had to be removed to prevent the patient from bacterial meningitis.

• Brand Name: POLARIS
• Type of Device: POLARIS 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 ; 3169353500
• MDR Report Key: 6119984
• MDR Text Key: 60992101
• Report Number: 3001587388-2016-16384
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Device Lot Number: B0002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• 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
• Patient Age: 56 YR