ELEKTA INC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-03 for ELEKTA INC manufactured by .

Event Text Entries

[4065357] Debilitating symptoms appearing after gamma knife. I was first diagnosed with trigeminal neuralgia, which lead to an mri, then the findings of the benign tumors on (b)(6) 2010. Gamma knife radiation was done at (b)(6) hospital on (b)(6) 2010. My neurologist is dr (b)(6) and the neurosurgeon was dr (b)(6). I was told the only side effect i may experience is the possible worsening of hearing loss in my right ear. Dr (b)(6) referred me to the elekta website for info pertaining to gamma knife. The statement "pin-point accuracy" on the website gave me trust and confidence in the procedure. After undergoing gamma knife, some symptoms began quite quickly, consisting of a foggy head, tingling in hands, blurry vision, and confusion with left and right directionality and spatial relations difficulty. To add to all that i had and still have the trigeminal neuralgia pain. I have burning in my shoulder blades, arms and legs, and weakness and extreme heaviness in my arms and legs. I sometimes experience changes in perceptions in body temperature. Worst of all was a memory regression. It was humiliating memories only. Regressing in a timeline, backwards, along with the memories were feelings and the level of maturity to which i still have difficulty dealing with. Within one year after radiation, i put myself into therapy because i had a memory surface of being raped when i was a young child. I have had memory difficulties in other ways as well. I could not perform at jobs i had done in the past. I was fired from two jobs. I have difficulties doing basic skills that i was able to complete in the past. I repeat sentences, ask the same questions and drive family and friends crazy. About three months after radiation i had severe pain in my face and head and went to the emergency room. It was so excruciating that i was kicking the wall while there. I was not given an mri, instead just put into the psychiatric ward for the day and sent home. I have since complained about many more symptoms surfacing, to which only taking my medications more and more frequently to alleviate the symptoms were helping. However, the effectiveness of the medications seems to be wearing off. The doctors have been dismissing my complaints and concerns and stating it is nothing more than anxiety and depression and that i exaggerate my symptoms. I have asked for them to review all my mri's with me but have been stonewalled to date. I have noticed that my mri reports have only been compared to the one after my er visit. Why are they not comparing it to the (b)(6) 2010 mri? That is the first mri prior to gamma knife. However, all the reports show no change in the tumors. All this raises my suspicion that something was done incorrectly during the procedure or something went wrong. I am left with much confusion and distrust. I am extremely frightened; i do not feel well and want nothing more than to know what was done to me and what i can expect to happen in my future. My symptoms keep getting worse and the doctors are making me feel like nothing more than a lab rat. A treatment should not leave a pt worse off than the condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5034199
MDR Report Key3610416
Date Received2014-02-03
Date of Report2014-01-19
Date of Event2010-12-09
Date Added to Maude2014-02-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameELEKTA INC
Generic NameGAMMA KNIFE
Product CodeIWB
Date Received2014-02-03
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2014-02-03

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