MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number NEU_INS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Hip Fracture (2349)
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Event Date 09/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Literature citation: angeli ca, boakye m, morton ra, vogt j, benton k, chen y, ferreira ck, harkema sj.Recovery of over-ground walking after chronic motor complete spinal cord injury.The new england journal of medicine.2018;379(13):1244-1250.Doi: 10.1056/nejmoa1803588.Outcomes attributed to adverse events: other: hip fracture.Date of event: please note this date is based off of the article¿s publication date as the specific event date was not provided in the published literature.Describe event or problem: it was not possible to ascertain specific device information from the article or to match the reported events with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Common device name: device used for off label indication.The indication the device was used for was the treatment and rehabilitation of a spinal cord injury.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Literature abstract: persons with motor complete spinal cord injury, signifying no voluntary movement or sphincter function below the level of injury but including retention of some sensation, do not recover independent walking.We tested intense locomotor treadmill training with weight support and simultaneous spinal cord epidural stimulation in four patients 2.5 to 3.3 years after traumatic spinal injury and after failure to improve with locomotor training alone.Two patients, one with damage to the mid-cervical region and one with damage to the high-thoracic region, achieved over-ground walking (not on a treadmill) after 278 sessions of epidural stimulation and gait training over a period of 85 weeks and 81 sessions over a period of 15 weeks, respectively, and all four achieved independent standing and trunk stability.One patient had a hip fracture during training.Reported event: it was reported a (b)(6) male patient experienced a ¿spontaneous hip fracture¿ as ¿he was stepping on the treadmill with body weight support.¿ the event occurred after the patient had been training for one week while using a spinal cord stimulator (scs).It was noted the issue occurred without a fall and that the patient resumed training one year later.When the patient returned to the study, after 68 sessions, they were noted to have developed ankle edema on their right side.It was noted the patient had suffered from a t4 spinal cord injury 2.5 years prior to enrollment in the study that left them with no movement or sensation below that level.Following the study, the patient was able to independently swing their leg during each step while on a treadmill and was able to stand with a walker; the patient could not do these actions when the scs was off.There were no further complications reported or anticipated.
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