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: VARIAN MEDICAL SYSTEMS LINEAR ACCELLERATOR; ACCELERATOR, LINEAR, MEDICAL
  • 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
 

VARIAN MEDICAL SYSTEMS LINEAR ACCELLERATOR; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number CLINAC IX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)
Event Date 04/26/2017
Event Type  Injury  
Event Description
Prostate cancer was diagnosed in 2016 and i chose external beam radiation therapy.The 9 week course recommended by (b)(6) ran from (b)(6) 2016 through (b)(6).By (b)(6) 2017, i developed severe left leg pain.It progressed to left foot drop by (b)(6), 2017.On (b)(6) 2017, i developed severe right leg pain.It progressed to right foot drop by (b)(6) 2017.I now need physical aids to walk.Testing ruled out other potential causes for foot drop.Radiation induced neuropathy was the cause.The fda requires written side effect warnings for medical devices.Why are there no neuropathy warnings on xray and radiation procedures? (b)(6) has no warnings; likewise (b)(6), its consumer education website.The latter has refused to post my story, my problems, or radiation therapy as a neuropathy risk.They ignore it.Installed at (b)(6) hospital, (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINEAR ACCELLERATOR
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS
MDR Report Key8596967
MDR Text Key144739789
Report NumberMW5086502
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCLINAC IX
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age72 YR
Patient Weight88
-
-