![]() ![]() Most of these devices have been approved by the FDA with little clinical testing, however, and the agency's data shows that stimulators have a disproportionately higher number of injuries compared to hip implants, which are more plentiful. Medical device manufacturers insist spinal-cord stimulators are safe - some 60,000 are implanted annually - and doctors who specialize in these surgeries say they have helped reduce pain for many patients. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports. Patients report they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. They account for the third-highest number of medical device injury reports to the Food and Drug Administration, with more than 80,000 incidents flagged since 2008. and as a treatment for an aging population in need of pain relief.īut the stimulators - devices that use electrical currents to block pain signals before they reach the brain - are more dangerous than many patients know, an AP investigation found. Companies and doctors push them as a safe antidote to the opioid crisis in the U.S. "But look at me."įor years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. "I thought I would have a wonderful life," Taft said. Today, the 45-year-old Taft is virtually paralyzed, barely able to get to the bathroom by himself. After an operation to repair it, he said, the device shocked him so many times that he couldn't sleep and even fell down a flight of stairs. ![]() Precision Spinal Cord Stimulator System please refer to the Precision Spinal Cord Stimulator System Clinician Manual.Taft's stimulator failed soon after it was surgically implanted. The Boston Scientific Neuromodulation Spinal Cord Stimulator (SCS) Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following:įailed back surgery syndrome, intractable low back pain, and leg pain. In other cases, general anesthesia may be administered.īesides a cordless remote control, the patient will also receive a portable, cordless charger and a base station for the charger. Patients may remain awake during this procedure, under local anesthesia and light sedation. In this case, the paddle lead is placed at the target site during the surgical procedure. In some cases, a physician may recommend a surgical lead, also known as a paddle lead. The leads may be inserted in a procedure similar to an epidural. If they decide to go forward, then the patient will undergo another surgical procedure to surgically place the Precision™ Implantable Pulse Generator. 1 Permanent ImplantationĪfter the “test drive”, the patient and physician decide whether or not spinal cord stimulation is a therapy option. ![]() This trial period gives the patient the opportunity to decide if SCS manages their pain. The external version is typically worn anywhere from a few days to one week. The patient also gets a wireless remote control so they can increase or decrease the electrical impulses to manage their pain. Once the physician locates the “sweet spot,” the leads are connected to an external trial stimulator that is tucked inside an external belt. As a part of the procedure, the patient may give the physician feedback on where to place the leads for maximum pain reduction. During the “test drive,” insulated leads are inserted through a needle or small incision in an anesthetized area near the spinal cord. One of the advantages of SCS therapy is that the patient gets to “test drive” an external version of the device to see if spinal cord stimulation is a treatment option for their pain. ![]()
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