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.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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It was reported that they were never given a patient (pt) programmer so they never had a way to turn the therapy off or on so the pt would have to travel back and forth to have their implant turned off for any tests/procedures they needed therapy off for.Patient said because of this reason their healthcare provider (hcp) had turned their deep brain stimulation(dbs) off in the office, pt said dbs was currently off.Pt said that the hcp said they couldn't order a patient programmer for the pt and redirected pt to the manufacturer (patient services (pss) also reviewed that hcp/the manufacturer can assist pt with how to turn therapy on/off with 37751 recharger if needed).Pss reviewed that patient programmer is prescribed device ordered by hcp but that pss could send message to field to provide visibility to situation.Patient said they now lived in a nursing home and they hadn't charged their implant battery in at least over 6 months.Pt said they didn't have their 37751 recharger with them and that they would be able to get their recharger from their home sometime next week.Pss reviewed information about possible overdischarge of implant battery.Patient said that they wanted to use the dbs therapy now because they had been taking medication instead of using the therapy and would like assistance having implant charged back up.Pss sent message to field and redirected pt to hcp.No symptoms were reported.Additional information was received from the manufacturer's representative (rep) stating that they did physician recharge mode with the wireless recharger.The patient got a normal recharge screen and charged for 2.5 hours.When the rep tried to connect with the clinician tablet today, the battery was depleted.Technical services( ts) reviewed that implant battery can be unstable after overdischarge, thus patient should continue to monitor battery level and recharge to hopefully stabilize the battery.Ts also reviewed there is a chance the battery can be damaged enough that it will continue to no hold a charge.Rep to work with patient to recharge and assess further.Rep said patient hasn't recharged in 1.5-2 years.
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