MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
High impedance (1291); Unable to Obtain Readings (1516)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/23/2014 |
Event Type
malfunction
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Event Description
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It was reported that during the implant procedure there was an impedance issue.Impedance testing was performed and results were high, indicating greater than 4000 ohms and ¿???¿ values.Specific electrodes with the issue were 01, 02, ???, and c2.As a result of the event, the device was never implanted and a different product was used instead.No patient symptoms reported.
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Manufacturer Narrative
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Concomitant medical products: product id 3037, serial# (b)(4), product type: programmer, patient; product id 3 889-28, lot# va0k32w, implanted: (b)(6) 2014, product type: lead.(b)(4).
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Manufacturer Narrative
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Final analysis of neurostimulator model 3058 (lot # njy257986h) showed no anomaly found.
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