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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA POLARIS SPV VALVE ADJUSTABLE ANTECHAMBER50-300; VALVE ADJUSTABLE POLARIS WITH RESERVOIR
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SOPHYSA POLARIS SPV VALVE ADJUSTABLE ANTECHAMBER50-300; VALVE ADJUSTABLE POLARIS WITH RESERVOIR Back to Search Results
Model Number VALVE POLARIS
Device Problem Detachment Of Device Component (1104)
Patient Problem Headache (1880)
Event Date 02/14/2014
Event Type  malfunction  
Event Description
Spva-300 was implanted in (b)(6) 2010.As the patient suffered from headache.The surgeon checked the system under x-ray to find the reservoir detached from the valve.He extracted the system and implanted spva.Then, the condition of the patient improved.
 
Manufacturer Narrative
The incident has been reported to the manufacturer on 03/28/2014; results of analysis will be developed in a follow-up report.
 
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Brand Name
POLARIS SPV VALVE ADJUSTABLE ANTECHAMBER50-300
Type of Device
VALVE ADJUSTABLE POLARIS WITH RESERVOIR
Manufacturer (Section D)
SOPHYSA
orsay
FR 
Manufacturer Contact
5, rueguy moquet
orsay cedex 91400
69353500
MDR Report Key3952163
MDR Text Key15325284
Report Number3001587388-2014-00136
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 04/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVALVE POLARIS
Device Catalogue NumberSPVA-300
Device Lot NumberX0080
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/17/2014
Is the Reporter a Health Professional? Unknown
Date Manufacturer Received03/28/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
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