MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number	SPVB-2010
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Missing ifu sent to the distributor.Missing ifu, no issue with the device.
Event or Problem Description
Missing component: the valve was delivered to (b)(6) without the ifu in spanish, only the french/english booklet.

• Brand Name: POLARIS
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6673169
• Report Number: 3001587388-2017-17229
• Device Sequence Number: 46111
• Product Code: JXG
• UDI-Device Identifier: 03760124131338
• UDI-Public: 03760124131338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 06/26/2017

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: Other
• Device Model Number: SPVB-2010
• Device Catalogue Number: SPVB-2010
• Device Lot Number: D0662
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/28/2017
• 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: Other