It was reported that the caller and the patient were attempting to charge, and charging was taking very long, and they did not get past 50%.Reviewed screens and icons and determined they were currently charging the 3rd quartile.Reviewed the duration associated with charging at 4 bars blackened, and they could get 8 bars.The caller reported they had been recently sent new external equipment.Reviewed the need to remain stable and keep the 8 bars, or charging would take longer.The caller will watch the charging and call back if they need to.The caller noted the charger was getting warm but not too warm.No symptoms/complications were reported.
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Continuation of d10: product id neu_recharger_acc lot# serial# unknown product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: neu_recharger_acc, serial/lot #: unknown, medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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