Model Number NEU_INS_STIMULATOR |
Device Problems
Unintended Collision (1429); Energy Output Problem (1431)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271)
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Event Date 04/26/2016 |
Event Type
Injury
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Event Description
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Information was received from a patient with an implantable neurostimulator (ins).It was reported that the patient was in an accident on their motorcycle and hurt their left arm and left foot.The patient reported that they had to ¿slice him open and put cadaver parts in him.¿ the patient reported that they stopped getting relief from their ins in 2016.The patient noted that they were looking at getting a pump implanted.No further complications are anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional review of original source information found that the patient had a spinal cord stimulation system put in, in 2005.The date that the patient had his motorcycle accident remains unknown.Additional information was received from a consumer regarding the patient on (b)(6) 2018.It was reported that the patient had the stimulator placed about 10 years ago.The patient noted that the stimulator still works, but starting about 3 years prior to the report, the stimulation therapy stopped working for the patient¿s pain.The patient is working with a physician and plans to have a fentanyl pain pump implanted on (b)(6) 2018.When the patient is having the pump placed, he plans to remove the implantable neurostimulator, but leave the leads in due to potential scar tissue.The patient mentioned that he had a minor stroke about 6-7 years prior to the report and did not confirm if the stroke was related to the stimulator.The patient¿s pre-existing medical conditions include being run over by a forklift and has been on fentanyl for 20 years at 200 micrograms.This was the reason for implant.
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Search Alerts/Recalls
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