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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ENTERRA THERAPY SYSTEM GES GASTRIC NEUROSTIMULATOR

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MEDTRONIC ENTERRA THERAPY SYSTEM GES GASTRIC NEUROSTIMULATOR Back to Search Results
Model Number 3116
Event Date 05/26/2009
Event Type  Injury  
Event Description

It was implanted on (b)(6) 2009 with the enterra therapy gastric nerve stimulator, also known as 4-5 other names. Ges, gastric neurostimulator device, gastric nerve stimulator and the device never worked in helping me with my gastroparesis. I have had 2 hospitalizations after i had it implanted from having severe high glucose numbers, severe heart pains due to my stomach being backed up and not being able to go to take a bm for over 15 days. I had wanted out after my device had the batteries dead, which i told to a representative from medtronic in person in (b)(6) 2011. I am a type one brittle diabetic and have had uncontrollable sugars for 29 years. At that time, the rep from medtronic ((b)(4)?) told me that it was confirmed that the batteries of my device were infact dead and that i should get the batteries replaced and or she said "we have a new one and that i should try that. " i clearly stated that the device i have in me never worked, has caused me pain, had and still does to this day electrical shocking and all i wanted was it taken out. She, rep from medtronic, stated that (b)(6) probably won't pay for it if i wasn't going to have another/new one replaced. I recently have been trying to work with a lawyer for my device. I also recently just found out about 4-5 months ago that the fda had my specific device, along with many others as a clas 11 recall on (b)(6) 2009. I am in shock that i was and still have never received any phone call, letter or any type of notification due to this device. As well as (b)(4), rep from medtronic, at the doctor's office not ever mentioning that there was a recall of my device a couple of months but in the same year i had mine implanted. I have had severe pain to my left side area and have my side going towards the back in the same area as my devices and the area is inflamed and about 1 and 1/2 years ago and had an ultrasound done and to make sure it wasn't my kidneys. Which the ultrasound report came back with it not having to do with my kidneys and the doctor was unsure of the findings and told me i needed the device out. All of my doctors have told me i have to get it out especially since the batteries have been dead for the last 3 years. I understand why i had to find out on my own, had to be help from god, allowing me to try to research and finding how many implantable medical devices are still being down especially from medtronic when they are supposed to help, not harm and finding that medtronic had in the past "withholding crucial information" on their medical devices and other products from public and the courts. Medtronic states these devices. But they actually have damaged my health, the left side and whole area surround the device in constant pain and tender on a 24 hour basis. I am hurting more and more as each day has passed and am looking in to a general surgeon to take it out. My life is worth more than any one can imagine due to what "profanity" i've been through in my life and actually believing in our human race to find out how much humans lie even when it had to do with someone that believes and hopes for something to help or at least live up to what this device was supposed to deliver. I feel medtronic is in business for the price of their products that they make and to say they help. When i read that medtronic implanted people with pacemakers knowing before hand that their batteries were in fact defective. Who in the (profanity) are they to put any human's one life at risk of any type of wrongful information/ defective/ recalled/ useless, harmful products/medical devices being untrue to what they say in trying to help. It makes me sick to think that medtronic is still in business. I have been sick and have lost track of time to realize i am waiting for help, to find i am the one that found out after on my own and live with pain in stress and anxiety about the device i have in me that never did what its intended use was. I wonder why i never got notice of this recall.

 
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Brand NameENTERRA THERAPY SYSTEM
Type of DeviceGES GASTRIC NEUROSTIMULATOR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key4251259
Report NumberMW5039016
Device Sequence Number1
Product CodeLNQ
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number3116
OTHER Device ID NumberTHE DEVICE IS DEAD AND INSIDE

Patient TREATMENT DATA
Date Received: 11/05/2014 Patient Sequence Number: 1
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