Device evaluation summary: the reported reading deviation was verified during service.Medtronic service noted that the back housing was broken, a thick blood stain was observed on the lever and during testing a single channel stopped suddenly.The issue was resolved by replacing the back housing and cleaning the instrument.Post-repair testing was performed per specifications.Conclusion: the complaint is confirmed for the act plus instruments reading deviation.The issue was verified during service when medtronic service noted that the back housing was broken, a thick blood stain was observed on the lever and during testing a single channel stopped suddenly.The issue was resolved by replacing the back housing and cleaning the instrument.Preventive maintenance/testing was performed per specifications.No patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.No further actions to be taken at this time.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.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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