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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA POLARIS POLARIS ADJUSTABLE VALVE

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SOPHYSA POLARIS POLARIS ADJUSTABLE VALVE Back to Search Results
Model Number SPV
Device Problem Device Inoperable (1663)
Patient Problem Hydrocephalus (3272)
Event Date 07/05/2017
Event Type  malfunction  
Event Description
A valve was implanted on (b)(6) but did not seem to operate although no anomaly could be detected during surgery. The valve was explanted and replaced the following day.
 
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Brand NamePOLARIS
Type of DevicePOLARIS ADJUSTABLE VALVE
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer (Section G)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer Contact
jean-christophe audras
5 rue guy moquet
orsay, 91400
FR   91400
MDR Report Key7078443
MDR Text Key94143339
Report Number3001587388-2017-17459
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K031097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPV
Device Catalogue NumberSPV
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
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