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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Information was received from a patient (pt) regarding an external device.It was reported that they are seeing a rm06 error code, and states that when they are charging the implanted neurostimulator (ins) the screen either "screen shuts off or goes completely white or says to replace controller battery yet it says controller is at 90 percent".They said this started on thursday and said it "took 6 hours to charge on saturday because it kept shutting down".They said the recharger (rtm) is not getting warm.Pt mentioned that they were sent an rtm replacement by the manufacturer.The pt called back with their equipment.Pt has been getting rm06, 'low battery' even though controller was at 90% charge.Also, when charging sometimes the screen goes to a white screen or goes dark.A replacement controller was requested.Pt also said they used to have adaptive stim and now cannot access it.On the call pt checked 2 groups and did not see as in the menu.They were redirected to their healthcare provider.
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