Model Number NEU_ENS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Nerve Damage (1979); Pain (1994)
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Event Date 03/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type: screening device.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacturer's representative and a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that after the patient's scs trial they had some pain and ended up going to the er.They noted that the er visit was long after the trial but it was unknown how long.The patient was found to have a spinal infection and had to have 3 level bone scrapped t12-l1 and now had nerve damage.The neurosurgeon didn't know if it was from the scs trial.The issue was noted as being resolved.No further complications reported.
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type: screening.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a manufacturer's representative.The representative didn't know what the cause of the nerve damage was and they noted that the patient was recovering.The issue occurred about 2 weeks after the trial.No further complications reported.
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Search Alerts/Recalls
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