MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE / 5 PRESS.

Model Number SPVA

Device Problems Device Difficult to Program or Calibrate (1496); Pressure Problem (3012)

Patient Problem Hydrocephalus (3272)

Event Date 08/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The patient showed low icp symptoms.The initial pressure was set at 110mmh2o, and then turned to 150mmh2o, but no improvement.Then it was turned to 200mmh2o, and still no improvement, the patient get better when he lied down but he had a headache when he sit or standup.So the doctor judged that the valve had a problem and explanted it.He replaced it with the same model(spva), with the pressure set to the 200mmh2o, and the patient get evidently improved, no headache when sit or standup.

Manufacturer Narrative

The device investigation results - visual testing: valve and reservoir are clean inside and outside.This is certainly due to the numerous test rinses by the doctor.- the device has no obstruction or leakage problems.- the programming is conform before and after soaking for 24 hours in bleach.The pressures are in conformity.As a restult, the device is conform to its specifications, the root cause remains unidentified.

Event Description

The patient showed low icp symptoms.The initial pressure was set at 110mmh2o and then turned to 150mmh2o but no improvement.Then it was turned to 200mmh2o and still no improvement, the patient get better when he lied down but he had a headache when he sit or standup.So the doctor judged that the valve had a problem and explanted it.He replaced it with the same model(spva), with the pressure set to the 200mmh2o and the patient get evidently improved, no headache when sit or standup.

• Brand Name: POLARIS ADJUSTABLE VALVE / 5 PRESS.
• Type of Device: POLARIS ADJUSTABLE VALVE / 5 PRESS.
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay 91400 ; FR 91400
• MDR Report Key: 10481145
• MDR Text Key: 214344743
• Report Number: 3001587388-2020-20457
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Device Lot Number: H004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR