Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2021, product type lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2021, product type lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 31-aug-2009, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 28-aug-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that¿the patient reported to the emergency room (er) in (b)(6) of this year with pain, nausea and vomiting.They also ended up in the er for the same reason from (b)(6) 2021.The physician took them to the operation room (or) today and discovered the leads were knotted behind the battery and one of them had fractured.The patient decided to replace both leads.The patient stated that it looked as though the patient was a twiddler.The leads were replaced and issue resolved.
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