MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problem
High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 977c265, serial#: (b)(4), implanted: (b)(6) 2020 product type: lead.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 manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that the patient was not experiencing symptoms, but rather was seen for normal post-operative reprogramming.The rep checked impedances per normal protocol and the top two contacts on the right lead had red x's, indicating impedances >40,000 ohms.The rep reprogrammed around the contacts and the patient was getting great relief.The issue resolved.
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