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Boston scientific dynagen mini inserted cardiac device.First there was never any warnings or information provided to me that the leads in this device could cause damages to a person's veins and can scar the veins to where blood will not be able to flow through.Causing major restriction of blood flow which is life threatening that a person will have to undergo further surgeries and expenses.There is much deception in the selling practices of these devices that dr's are not honest and the fda ignored previous complaints about this product when i submitted a first complaint that the screws are faulty and had to undergo a surgery already for this device.Fda did not even post the complaint i had submitted and now my life is in danger again from another issue with the dynagen device.The hospital on the first device was allowed a kickbacks warranty payment from boston of (b)(6) refused to credit my insurance or credit my bills.How much money will hospital be paid from this second do over surgery from more issues from dynagen.Fda has known of screw issues and has known about vein damages and life threatening issues and has hid this information from consumers failed to report failed to post incidents by picking and choosing at the expense of my life and insurance what fda wants people to know so that the profits for hospitals and boston scientific are not hundred i should sue the fda for failing and hiding issues about dynagen mini.Reference: 2124215-2018-08678.First type of icd inserted (b)(6) 2017.The first icd was implanted with loose screws allowing the port to pool with blood.This caused me to undergo excruciating pain from "jerking" for nearly 2 days straight on (b)(6) 2017 i had to call for an ambulance because it was causing severe abdominal pain.The jerking was like if a person stuck a wet finger in a light socket.There were ten calls and five trips to the emergency room due to initial implant swelling and a broken device that was ignored for nine months before a change to fix the problem doctor caused.This doctor was let go in (b)(6) of 2022 and is no longer working there.The second attachment provides details from boston of the model type dynagen and serial information.I do also have the 911 call recording from when this happened.I was having problems with swelling and severe pain in the device area after insertion.Call the dr several times a month after insertion calls right up to having to go to the hospital.I was told to quit calling because i complained too much and if i had a problem to go to the er.I filed for the warranty and the warranty stated this would go to the hospital in my name, however the (b)(6) refused to return it to me, refused to apply it to my bills and just stole it and made me suffer needlessly for nine months before they realized there was truly a problem and the icd had to come out once the dr realized the screws to the battery port were broken.Followed up by boston informing the hospital the dr broke the device before inserting.The state of (b)(6) refused to compensate me for their employee damaging the device before implanting, implanting a broken device and refunding me the (b)(6) at a minimum for the pain and suffering i had to endure from their employees.The implanting of the device on top of bones, as the user's manual clearly states that the device should not be implanted subcutaneously will cause damage in small thin people.I weighed 93 pounds with no body fat.They are to implant subpectoral to avoid do over surgeries from having to move the device and rerun or work on lead threading.I reported this all to the fda in (b)(6) of 2018 and the drs and the university did not file a med alert reporting the issues encountered.New injuries and damages due to change out of one type of icd to a different icd.(b)(6) 2018.That needs to be reported to the fda.Model?serial of new device: : (b)(4).Inserted (b)(6) 2018 to replace broken device went from a dynagen to a dynagen mini.From (b)(6) of 2018 until (b)(6) of 2020 i experience pain right under my left breasts where the lead is running.Every time i would eat the pacing would hurt so bad that i could not eat.I was feeling the pacing continuously up until 2020 to find out that the second pacemaker was set at a higher pacing mode than what it should have been for a person of my size.In 2020 the electrologist, which was a new one dr (b)(6) was not able to handle care for me no further, she determined that the pacing was set extremely high and turned it down and i have not had trouble with the pain after enduring for nearly two years because these employees/drs won't help this electrologist located the problem for high pacing.What further damages would i have encountered if this icd went off , it was set to defibrillate someone who is 200 lbs not 90lbs.In (b)(6) of 2020 i reported to dr.(b)(6) my cardiologist that i was feeling like my neck was gorging with blood.Every time i bent over my whole head would turn red.They did nothing.In (b)(6) of 2020 i again told dr.(b)(6) my neck was feeling like it was gorging with blood, getting light headed, flushing in my head.Again they did nothing and in fact dr.(b)(6) told me i did not need a cardiologist anymore and cancelled all other appointments and treatments.I had to go without a cardiologist for a year because the employee told me my heart was as good a new and i didn't need a cardiologist anymore.(b)(6) of 2021.I reported to my drs again that i was feeling like i was gorging in my neck, all my blood vessels are popping in my main artery of my neck, and now i was having stomach varicose veins popping out in two spots in my abdomen, i was having bruising under my left breasts and right along the line of the leads.Pain in my diaphragm area.They ran a test to check my liver in (b)(6) of 2021.The liver test showed that there is not enough oxygen running through my svc value from my heart to my liver but my liver was not showing damage from deprivation of blood.They told me that the flushing in my neck, and pain in my abdomen and the varicose veins appearing was because of me losing weight.Every time i eat i get sick, get the craps as well.But they said it was because i was now 86 pounds and losing weight causes varicose veins in your abdomen and the doctors did not follow up any further even with test results showing that there was a heart issue, valve issues or vein issues.(b)(6) 2022.I had several more veins popping in my abdomen, now pain in my abdomen is really bad.Reported this to my "new" doctor to find out that there are some very serious issues related to the insertion and change out of one type of icd to a different type of icd.From (b)(6) of 2022 until (b)(6) 2022, i have now my entire stomach is covered in a lot of varicose veins and it has reached my groin area and causes pain when i poop, which i already provided pictures taken last week, this week its reached my groin to the fda in my initial report, my face is starting to swell, my main neck veins popping, hard to breath, to find out now that the leads that were implanted has scarred my veins not allowing the blood to flow through the right way, i am scheduled for a cta scan and an echo to determine where the blood clots are, how much damages is now in my veins, how much more surgeries and fixes i will have to endure due to what this hospital and doctors did to me and no where was i informed the having a icd would damage my veins to a point of scarring, i was never told the icd would cause my svc value to be damaged, or varicose veins would occur all over my body and belly due to lack of blood flow due to the icd leads.There needs to be more reporting from the health field to fda regarding all the damages that a person could encounter by having an icd.There should be accountable for physicians who screw up initial implants by breaking devices than having to do a change out from one type to a different type of icd will cause pacemaker induced superior vena cava syndrome or other likeness of damages.Venous constriction is not a fun illness and in fact causes pain in the shoulders and shoulder blades like someone is sticking you with a knife, it causes pain in the diaphragm where the blood is backing up causing clotting and varicose veins that are painful.All over your stomach and groin area.Likewise, once someone reports gorging in the neck, bruising under the heart along the line of the leads then someone should be following up immediately not tell you that you don't need a cardiologist anymore and even when the test showed a year ago i had blood flow issues through the svc, no one acted and there should be something written to inform these medical professionals that these symptoms are deadly and should not ignore.All signs of venous constriction has occurred and occurring and was ignored for the past year even with reports stating there were issues , when blood pressure reports shows 100/63 there is an issue when a person suffers from bradycardia and ventricular tachycardia.In the past two weeks this condition has worsened to the point now i am having muscle spasms in my left rib cage severe pain in my gut and along my left rib cage.All this suffering i endure all because information was not provided, doctors not acting on symptoms and doing differential diagnosis the past two years, setting pacemakers too high, breaking pacemakers defibrillators and having to do change outs within a year causes issues.I am told by the state of (b)(6) i didn't do enough on my part to exhaust all the remedies available to me for damages the joint commissioners office director (b)(6) says that i have exhausted all my remedies because the university of (b)(6) hospitals and clinics don't have to do anything in returning the (b)(6) warranty to me or use it for my medical bills, they don't have to compensate me for damages and injuries associated with dr breaking and implanting a defective device, so there is now nothing i can do except get my insurance card out and pay for more repairs and damages this whole situation has caused me and i want it duly noted in the fda these types of issues a patient will encounter due to changing out icd to one type of pacing to another and change out of generators of icd.It causes a person's veins to be damaged, your svc to be damaged, varicose veins that are nasty and sore in your belly.Neck gorging with blood (flushing), pain in your shoulders and left arm, headaches, dry cough, lightheadedness chest turning red with big veins all over or spider veins, bruising in the chest, boobs and belly are all signs of icd leads are scarred and blood not getting where it needs to be and oxygen deprivation in blood and person are all related to icd change outs and icd leads.Fda safety report id# (b)(4).
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