Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead; product id: 97715, serial#:(b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator; product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead; product id: 97715, serial#: (b)(4), implanted: (b)() 2020, product type: implantable neurostimulator.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 06-feb-2016, udi#: (b(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a manufacturer representative regarding a patient who is implanted with a neurostimulator.It was reported that on 7/10, during an ipg replacement, 8-15 lead was stuck in 37714.When finally removed from old ipg lead appeared intact, but would not advance into 97715.Additional information was received from a manufacturer representative regarding the patient on (b)(6) 2020.The reason for the replacement was due to end of service of the 37714.The cause of the lead being stuck in the old implantable neurostimulator and not advancing into the new implantable neurostimulator was not determined.The lead is still implanted, and it is to be determined whether or not it can be used.It showed high impedances during intraop testing when it was advanced into the implantable neurostimulator as far as it would go.There were no patient symptoms or complications reported.
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