Continuation of d10: product id 37761, serial# (b)(6), product type recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6).Analysis of the 37761 desktop charger (dtc) (b)(6) revealed bent connector pin.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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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It was reported that recharger turns off after about 5-10 minutes after patient starts to charge ins and shows a picture of a plug.Patient states no damage seen on desktop charger (dtc) or recharger.The patient called back to report that they received a new dtc, but it did not resolve the issue.The patient stated that the recharger still does not take a charge from the dtc, and they see the 'charge your recharger' warning screen even when the dtc is connected to the recharger.The patient confirmed the power indicator on the ac power supply was lit green.Patient's wife called back to request recharger be sent to pt because recharger still wasn't charging after pt received replacement dtc and pt hadn't charged in 4 days.Patient representative (pt rep) said they talked to manufacturer representative and was told to request the recharger because the patient wasn't interested in updating to the wireless recharger (wr).Pt rep said pt had tremor so even with the recharging holster charging was difficult because the pt moved around.Pt rep said only way pt was able to charge was with adhesive discs so pt was going to stick with recharger.Pt rep mentioned pt had dbs hcp appointment in (b)(6) 2022.
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