Product analysis #703466434: on-site service was completed.The complaint was confirmed.The location sub-system (lss) was replaced and the system passed testing.The lss was returned and evaluated.The lss device was installed into a console for testing.Testing was performed and verified that the replacement lss device allowed the v7 system to boot and start the procedure application.A hardware major fault occurred when the procedure application was launched and the location board was plugged in.If the location board was left unplugged, the hardware fault would not occur until the location board was plugged in.When the fault occurred, the following information was on the v7 monitor: hardware major fault transmitter over current fault occurred.The procedure will be closed.Please contact technical services.Error (#572) the hardware major fault was generated as a result of the transmitter board circuit in the computer powering up after the procedure application was launched and the location board was plugged in.Once the transmitter board circuitry was energized to power the location board antenna, the hardware major fault occurred.The hardware major fault was the result of a fault of the transmitter board circuitry which powers the antenna.The transmitter electronic circuitry generated a hardware major fault when the transmitter circuitry was powered on to drive the location board antenna.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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