MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problems
Therapeutic Response, Decreased (2271); Electric Shock (2554)
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Event Type
malfunction
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Event Description
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It was reported that on friday prior to the date of this report the patient had another sudden loss of therapy.On the date of this report the clinician programmer was showing an out of regulation (oor) message during programming and a short was showing between electrodes 1-2.Impedances on (b)(6) 2014 were c/0-991, c/1-564, c/2-559, c/3-767, 0/1-933, 0/2-944, 0/3-1388, 1/2-89, 1/3-757, 2/3-743.The patient was programmed using 1-2, 2.7v, 120us and 185hz.Therapy impedance was 103 ohms, 23.7mz.The patient had gotten a shock when electrode z was conducted at 3v and was not getting the shock at 0.7v.No intervention or outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental mdr will be submitted.
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Manufacturer Narrative
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Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead; product id neu_unknown_ext, serial# unknown, implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v017959, implanted: (b)(6) 2007, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.(b)(4).
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