MEDTRONIC NEUROMODULATION SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 7426 |
Device Problems
Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Electric Shock (2554)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical product: product id: 7426, serial# unknown, product type: implantable neurostimulator.(b)(4).
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Event Description
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The patient's clinician reported via the company representative (rep) a shocking sensation when the implant was off.It was unknown if this was a sudden or gradual change.The patient has not been using the bilateral implantable neurostimulators (ins) and recently reported shocking.The clinician met with the patient yesterday and programmed the patient to 0v and verified system was off.The patient was sent home.Today the patient was still having shocking.It was unknown if the patient has had any recent medical test or emi environmental exposure.The patient was referred to a neurologist to determine if related to their disease state.If additional information is received, a follow up report will be sent.Reference manufacturer report# 3007566237-2015-02342.
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Search Alerts/Recalls
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