MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number	SPVA
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The valve doesn't meet its specifications concerning pressure setting.Corrective actions were applied to prevent any similar situation of rotor blocking.
Event or Problem Description
The device could not be adjusted in its sterile packaging.

• Brand Name: POLARIS
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6137804
• Report Number: 3001587388-2016-16247
• Device Sequence Number: 16340182
• Product Code: JXG
• UDI-Device Identifier: 03760124131307
• UDI-Public: 3760124131307
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K031097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: Other
• Device Expiration Date: 09/01/2020
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Device Lot Number: C0588
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 12/01/2016
• 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: Other