Continuation of d10: product id 97755, serial# (b)(6), product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) , udi#: (b)(4), h3: analysis of the recharger, product id: 97755, serial/lot #: (b)(6) found the controller won't power on when the recharger is plugged in.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Information was received from a patient regarding an external device.The reason for call was patient reported they were having issues recharging the implant, an unknown replace battery message would appear, and saw multiple screen layered over each other since summer of 2023.Agent had patient inspect the recharger cord, recharge plug , and the controller port.No visible damage detected.The controller did not recognize the recharger when plugged in and remained on "connect the recharger" screen 13.The troubleshooting steps did not resolve the issue.Email was sent to repair for a recharger replacement (exchange program).
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