I reported this all to St Jude and was told to try and charge more often for shorter periods and was sent two new antenna paddles. There was also a problem with sensations of bad pain at the IPG site like hot needles that happened sporadically. When it WAS charging it would get unbearably hot with pain lingering for a long period after the antenna was removed. Also, it was very difficult to get the charging antenna placed in a position in which would charge the IPG, I couldn't so much as sneeze or it would lose connection. After maybe 1-2 years I had to call in the St Jude people multiple times to try to adjust it down into the areas of pain which it was failing to do. The unit at first gave moderate relief of my pain but nothing like the trial unit had. After maybe 1-2 years I had to call in the St Jude people multiple times to try to adjust it down into th Hello, on I had an ANS stimulator electrode model #3214 and an ANS rechargeable IPG model #3716 implanted for severe lower back pain from lumbar disc herniation and degeneration in multiple levels. Hello, on I had an ANS stimulator electrode model #3214 and an ANS rechargeable IPG model #3716 implanted for severe lower back pain from lumbar disc herniation and degeneration in multiple levels. It would overheat I would also have shock like sensation that were debilitating at times. I had problems with the battery, burning and stinging. I had a Saint Jude’s Tens unit that did not supply any pain relief. Jude Riata lawsuits filed following the recall, the company failed to manufacture the leads consistent with the FDA approved processes, exposing patients to a risk of problems with the lead wire. According to allegations raised in several St. Jude Riata and Riata ST ICD leads, which were recalled after it was discovered that the small wires used to connect an implantable defibrillator to the heart may poke through the insulation. In recent years, problems with manufacturing defects have also been cited as the cause of problems with St. Jude reported the company has taken steps to correct the problem with the battery supplier by “implementing design improvements to the charger to address possible increased energy dissipation when the IPG and charger are misaligned or the IPG is located too near the surface of the skin.” The firm also advises patients who feel discomfort or pain to stop charging until the discomfort subsides and to adjust the position of the antenna and attempt more frequent recharging for shorter periods to avoid problems. The heat generation was a byproduct of energy dissipation that occurs when an electromagnetic field is used to inductively transfer energy between 2 objects, according to the letter. These burns were a result of batteries overheating while recharging. At least 127 of these reports pertained to the warmth and heating of the IPG, resulting in 29 explants, and 214 of Eon Mini IPG’s resulting in 43 explants. Implanted devices should not be immediately explanted, but closely monitored for malfunction.Ī total of 325 battery issues have been reported due to overheating problems, resulting in 72 removals and reports of first degree and second degree burns in at least three patients. Jude reports that it has taken steps to correct the problem with the battery supplier, suggesting that un-implanted devices should be returned to the company for a free replacement. Adverse effects of explant surgery can cause pain, scarring, infection and complications with anesthesia. These failures resulted in loss of pain relief and led to subsequent explant surgeries in some situations. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery.” Jude put forth a new cause for the problems in the letter, dated July 26, indicating they were caused by “ need to more frequently maintain and replace certain tools during the internal battery welding process by a St.
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