MEDTRONIC NEUROMODULATION RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37712 |
Device Problem
Energy Output To Patient Tissue Incorrect (1209)
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Patient Problems
Dysphagia/ Odynophagia (1815); Nausea (1970); Undesired Nerve Stimulation (1980)
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Event Date 06/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37712, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.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 consumer with two implantable neurostimulators (ins) for other chronic/intract pain (trunk/limbs), other upper quadrant sites, and spinal pain.It was reported even though she has turned her devices off, the patient is still feeling stimulation and she can't get it to stop.The patient states she has already turned stim off on both ins's.The patient states she does experience residual stim for about 24 hours after turning stim off but this time it's different.The patient states it won't go away and it's making her sick.Patient reported residual stim and nausea.Communication with the patient programmer showed the ins was off.The patient was redirected to their healthcare provider to have the device checked.The patient stated that she has been trying to take medicine but can't because it won't go down.It feels like something is stuck in her throat.No further complications were reported/anticipated.**omitted information related to (b)(4) ¿ lead in wrong location.**.
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