The main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Additional information was received from a legal representative of the patient.It was reported that patient had a significant low back problems for a number of years, resulting in two surgical procedures in 2008 and 2012.The procedure in 2012 involved a fusion with hardware from l5-l3.As a result of the significant low back difficulties sustained by patient, patient suffered from chronic pain.In about the end of 2016, patient sought out the advice and treatment from healthcare professional for intractable back pain.Patient was recommended to underwent a series of epidural injection in the low back in an attempt to alleviate or release control of the intractable low back pain, but to no avail.Thereafter, patient was recommended by healthcare professional to the spinal cord stimulation trial to help predict the efficacy of the potential implant and to make sure patient would not suffer from any allergies or adverse reaction to the device.The trial was completed in late (b)(6) 2016 that patient experienced some pain relief and had no a adverse reactions.Patient had the implant on 2017(b)(6), where the ins was implanted on the right side and ran the leads towards the spinal cord and accessory nerves.The leads were supposed to be placed in the epidural space at or around the area of significant pain, at this point, the patient's low back or lumbosacral spine.Immediately after procedure and waking up from anesthesia, patient complained that they had no feeling/sensation in their lower legs.Patient was assured by healthcare professional and staffs that was expected from the anesthesia and there was nothing to worry about.Over the next approximately 6 hours, patient continued to complained of not being able to feel anything below their legs and was, in fact, incognizant of bowel and bladder at that point.After some time, healthcare professional finally agreed to transport patient to an emergency facility.At the emergency department, a ct scan quickly revealed that the leads had, in fact, penetrated and were wrapped around patient's spinal cord and that perhaps the dura of the spinal cord had been penetrated by the leads and a significant bleeding and perhaps a hematoma was able to be seen.It was verified that a significant spinal cord injury had been sustained from patient as a result of the implantation of the device and that emergency surgery was necessary.During the following surgical procedure, healthcare professional saw that the leads implanted earlier had, in fact, traversed the spinal cord to t9 and had penetrated the spinal cord on several spots, causing significant nerve damage, causing a hematoma which could not be evacuated, penetrating the dura to cause a durotomy with resulting leaking of spinal cord fluid and blood.As a result, patient sustained paralysis of their body below the waist, and had been rendered incontinent of bowel and bladder, and will not be able to walk again, wheelchair bound and these injuries are most likely than not going to be permanent in nature.As a further result of the injuries, patient had suffered and/or may suffer physical and mental anguish and pain, suffering, inconvenience, emotional distress, shock and injury to the nerves and nervous system.Patient had been and/or will be deprived of the ordinary pleasure of life.No further complications were reported as a result of this event.
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