No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the polaris spectra system control unit (scu) for the navigation system was replaced.The system then passed the system checkout and was found to be fully functional.The scu was returned to the manufacturer for evaluation.Testing found that after a short time period, the unit would not recognize instrumentation.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Concomitant medical products: other relevant device(s) are: product id: 9 735820, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
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H2: vendor analysis was done.The fault was verified and isolated to the mainboard communications intermittence at a ball grid array chip.The mainboard had been replaced followed by product testing.Codes b01, c02 and d02 are applicable.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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