Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: kit svc o2 bi71000167 cblasy dbl shldmvs h3) no parts have been returned for analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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The system was serviced in the field and the umbilical cable was replaced.Codes b01, c02, and d02 apply.The umbilical cable, lot number 016 rev.D, was returned and analyzed.The umbilical cable failed bench test.There was an open between p4-d pin 27(red) and 28(green) and p1-d pin 5 and 11 respectively.Codes b01, c02, and d02 apply.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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