Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA POLARIS SPVA KIT B905S/BO19-10; POLARIS ADJUSTABLE VALVE KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOPHYSA POLARIS SPVA KIT B905S/BO19-10; POLARIS ADJUSTABLE VALVE KIT Back to Search Results
Model Number POLARIS VALVE
Device Problem Detachment Of Device Component (1104)
Patient Problem Paralysis (1997)
Event Date 10/21/2014
Event Type  Injury  
Event Description
The neurosurgeon implanted polaris valve spva-2010 in ((b)(6) 2014) so significant improvement then hyperdrainage signs (subdural slight detachment and paralysis vi).It was explanted about 18 days on (b)(6) 2014 and therefore the surgeon remplaced it with sm8-400.
 
Manufacturer Narrative
The incident has been reported to the manufacturer on (b)(6) 2014.Results of analysis will be developed in a follow-up report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLARIS SPVA KIT B905S/BO19-10
Type of Device
POLARIS ADJUSTABLE VALVE KIT
Manufacturer (Section D)
SOPHYSA
orsay
FR 
Manufacturer Contact
5, rue guy moquet
orsay cedex 91400
69353500
MDR Report Key4261758
MDR Text Key5104064
Report Number3001587388-2014-00040
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 11/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPOLARIS VALVE
Device Catalogue NumberSPVA-2010
Device Lot NumberZ0530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received11/03/2014
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 Age80 YR
-
-