MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHYSA ADJUSTABLE VALVE

Model Number	SM8
Medical Device Problem Codes	Decrease in Pressure (1490); Pressure Problem (3012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Suspision of chronic hypodrainage, despite the valve being in the low position.The valve had to be explanted.
Additional Manufacturer Narrative
The marks observed on the inlet connector lead us to suspect the use of metallic pliers during the manipulation of the valve.The use of such pliers is inadvisable because it can cause a loosening of the connector, leading to the uncalibration of the valve.The instruction for use of the sm8 valve contains a precaution against the use of metallic pliers.
Event or Problem Description
Suspicion of chronic hypodrainage, despite the valve being in the low position.The valve had to be explanted.

• Brand Name: SOPHY
• Common Device Name: SOPHYSA ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6026372
• Report Number: 3001587388-2016-16395
• Device Sequence Number: 868584
• Product Code: JXG
• UDI-Device Identifier: 03760124131093
• UDI-Public: 3760124131093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/01/2017
• Device Model Number: SM8
• Device Catalogue Number: SM8
• Device Lot Number: Z0115
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2016
• Supplement Report FDA Received Date: 11/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR