Product analysis: analysis was unable to conclusively confirm the customers comments regarding the pacer spike occurring before the p wave after activating pacing.There is not enough information from the log file to determine the cause of the error as reported by the user.There are no pictures or video of the scenario that may have provided information/insights as to what was occurring in this particular incident.The log file documents (2 hour session) where the user was implanting an implantable pulse generator (ipg) device.During the procedure the analyzer was accessed seven different times: three launches and four resumptions.The user (and patient) spent a long time for the implant due to issues they encountered.Tests performed during the procedure include lead analysis amplitude threshold test, egm amplitude test (i.E.Sensing test), and subthreshold lead impedance test.Without additional clarification it is not possible to fully understand what the user observed and meant by their descriptions.At this time, no conclusion can be made.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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