MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problems
High impedance (1291); Device Operates Differently Than Expected (2913)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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Event Description
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The arrangement of the patient¿s stimulation was unusual in that he developed high impedance on all the leads to the left of them as well as a disappointing functional response with tremor in his right hand occurring as he wielded his tools in a pale beating job.The lead was re-implanted in the left posterior subthalamic area and connected to the implantable neurostimulator (ins).This occurred in (b)(6) 2013.If additional information is received, a follow up report will be sent.
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Manufacturer Narrative
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Concomitant product: product id neu_unknown_lead, serial # unknown, product type lead.(b)(4).
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Search Alerts/Recalls
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