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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE SPV

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SOPHYSA POLARIS ADJUSTABLE VALVE SPV Back to Search Results
Model Number SPV
Device Problem No Flow (2991)
Patient Problem Hydrocephalus (3272)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
Pending device analysis. A follow up will be send when analysis is done.
 
Event Description
The spv implanted on (b)(6) 2020 was suspected of being blocked (obstruction suspected). On (b)(6), the flow seemed bad, the doctor tried to remove the spv and external drainage was performed.
 
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Brand NamePOLARIS ADJUSTABLE VALVE SPV
Type of DevicePOLARIS ADJUSTABLE VALVE SPV
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer (Section G)
SOPHYSA
rue sophie germain
besancon, 25000
FR 25000
Manufacturer Contact
hanta ranaivoson
5 rue guy moquet
orsay, 91400
FR   91400
MDR Report Key11100477
MDR Text Key224535244
Report Number3001587388-2020-20693
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPV
Device Catalogue NumberSPV
Device Lot NumberG050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2019
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: 12/31/2020 Patient Sequence Number: 1
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