Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000751, ubd: unknown, udi#: unknown product id: m021083c001, software version # 4.2.1.Product id: bi71000273, ubd: unknown, udi#: unknown.Product id: bi71000192, ubd: unknown, udi#: unknown.Product id: bi71000203, ubd: unknown, udi#: unknown.Product id: bi71000086, ubd: unknown, udi#: unknown.Product id: bi71000626, ubd: unknown, udi#: unknown.Product id: bi71000273, ubd: unknown, udi#: unknown.Product id: bi71000192, ubd: unknown, udi#: unknown.Product id: bi71000203, ubd: unknown, udi#: unknown.Product id: bi71000086, ubd: unknown, udi#: unknown.Product id: bi71000626, ubd: unknown, udi#: unknown.Product id: bi71000674, ubd: unknown, udi#: unknown.Product id: bi71000703, ubd: unknown, udi#: unknown.Product id: bi71000166, ubd: unknown, udi#: unknown.Product id: bi30000288, ubd: unknown, udi#: unknown.Product id: bi71000199, ubd: unknown, udi#: unknown.Product id: bi71000751, ubd: unknown, udi#: unknown.: a medtronic representative visited the site to evaluate the equipment.The rep completed a complete door realignment.It was noted that parts were worn.Codes b01, c07, and d02 are applicable.Additional system service was performed.The rep replaced door switches, door slides, rehomed the system, corrected x-drive stopping by repositioning the x-stage cover, adjusted door cable tension, performed door re-alignment, and replaced stripped turn-buckles during adjustment.Codes b01, c07, c13, and d02 are applicable.Software analysis was performed.It was determined that the issue was unrelated to software.Codes b01, c19, and d14 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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H2) the following product ids were returned unused and are no longer relevant to this event: product id: bi71000086, product id: bi71000192, product id: bi71000203, and product id: bi71000626 continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000151, serial/lot #: (b)(6) the cover was returned to the manufacturer pending analysis.Codes: b21, c21, d16 for the following product ids: bi71000203, bi71000674, bi71000703, bi71000166, bi71000199, bi71000751, bi71000273 codes: b17, c20, d15 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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