H3 : analysis summary : analysis of returned product of id 1112363 and lot # 0211114735 found that visually, the shaft of the sample was broken which would have resulted in the reported event.Under magnification, a portion of the shaft head of the sample was broken off.Functional testing is not required per d00435338 revision c.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that is likely related to the complaint due to physical damage.A2,b5 - updated with new information.H6 - previous fdm b21, fdr c21 and fdc d14 codes no longer apply.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.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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