MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE30-200 WITH SIPHONX; POLARIS® ADJUSTABLE VALVE30-200 WITH SIPHONX®

Model Number SPV-SX

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Hydrocephalus (3272)

Event Date 07/11/2021

Event Type  malfunction  

Event Description

The spv-sx valve was implanted to the skul of (b)(6) year old patient on (b)(6) 2021 (exact date not communicated).On (b)(6), follow up symptoms (disturbed consciousness and ventricular distention) were confirmed.When the doctor tried to change the pressure setting to 30 mmh2o, his attempt was unsuccessful.The valve had to be extracted and replaced on (b)(6).The removed valve could be adjusted to 30 mmh2o.

• Brand Name: POLARIS ADJUSTABLE VALVE30-200 WITH SIPHONX
• Type of Device: POLARIS® ADJUSTABLE VALVE30-200 WITH SIPHONX®
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquêt; orsay, 91400 ; FR 91400
• MDR Report Key: 12434054
• MDR Text Key: 283314848
• Report Number: 3001587388-2021-21435
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPV-SX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR