Model Number 37800 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Death (1802); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Cognitive Changes (2551)
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Event Type
Death
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.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 legal representative of the patient regarding a patient implanted with an implantable neurostimulator.After the patient was implanted with a stimulator on ¿(b)(6) 2016 they developed complications related to the device.The representative stated the ¿stimulator was in a defective condition and unreasonably dangerous for its intended or expected use and posed a risk of serious harm to the patient and others,¿ to which the patient was never warned about.¿due to the defective design and/or manufacturer the stimulator failed and malfunctioned and due to this the patient sustained injuries resulting in multiple harms (including physical pain, mental suffering, mental anguish, permanent injury, and permanent impairment of the power to labor and earn money), losses, and death due to complications related to the stimulator (on or about (b)(6) 2017).¿ relevant medical history includes gastric stimulation.
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Search Alerts/Recalls
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