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Model Number 24970A |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary:the device was not returned for analysis.However performance data collected from the device was received and analysed.Analysis of the device memory was performed and indicated a certificate renewal failure issue was experienced which was a known issue.The software of the mobile programmer was updated to latest version which resolved the issue.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the mobile programmer lost connection with the patient connector.The user removed the patient connector 3 inches which caused the mobile programmer application to indicate that it lost connection, followed by the tablet going red and it could not interrogate.It was noted that the tablet was 2 inches from the patient and that the patient was totally dependant.It was further noted that the user had wireless fidelity (wifi) turned off and that the user attempted to reconnect to the patient connector but the implantable device serial number would not pop up as an available patient connector to select.The user can usually swipe the mobile programmer application closed and restart it to resolve the issue, but on this occasion the user was pressed on time and used an alternative programmer instead.The issue was escalated to find a resolution for the user and has been resolved.No patient complications have been reported as a result of this event.
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Event Description
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The programmer software has been updated with issues resolved and the programmer is therefore not being returned for analysis.
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Manufacturer Narrative
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Additional information: b5, d3, h6.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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Event Description
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It was further reported that the issue occurred whilst the right ventricular lead was being tested through the analyzer.The programmer is expected to be returned for analysis.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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