Device evaluation summary: the reported battery indicator issue was verified during field service.The technician observed power supply voltages jumping +/- 1vdc from 30vdc and the power supply was unstable.The service technician replaced the batteries and power supply.The instrument powered on but the user interface (ui) would not power on.Further troubleshooting could not identify source of issue.The depot service technician found that the base unit had multiple error codes and they suspected that the field technician knocked r252 off of the system controller while replacing the batteries which caused the error codes.The issue was resolved by replacing the assy system controller module.Preventive maintenance was performed per specifications.Conclusion: complaint confirmed for the reported battery indicator issue during field service.There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Trends for issues with this product are reviewed at quarterly quality meetings.Batteries met their lifecycle requirements.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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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