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 SA POLARIS ADJUSTABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
  • 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 SA POLARIS ADJUSTABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number SPV-140
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem Hydrocephalus (3272)
Event Date 02/02/2019
Event Type  Injury  
Event Description
Patient had mri.The programmable shunt is conditional to 1.5 tesla with pressure setting to be checked before and after mri exposure per manufacturer website.Fsh mri guidelines indicate if patient doesn't have a appointment with neurologist to check.Shunt within 24 hours after mri, staff should obtain xray shunt series pre and post mri.Patient had a mri abdomen with programmable vp shunt.Shunt was disclosed on metal safety checklist.During a hand off of care, shunt was described to scanning tech as safe, when in fact the shunt was programmable.Without this occurring, patient slowly developed hydrocephalus, per university neurologist.Discovery of shunt pressure setting modifications, due to mri environment, was not until one month after patient was discharged from hospital original admission.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLARIS ADJUSTABLE VALVE
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
SOPHYSA SA
MDR Report Key8550837
MDR Text Key143373372
Report NumberMW5086167
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberSPV-140
Device Lot NumberA0711
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age46 YR
Patient Weight102
-
-