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Model Number UNK_CARELINKSOFTWARE |
Device Problems
Computer Software Problem (1112); Wireless Communication Problem (3283)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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Information received by medtronic indicated that the customer reported not connected, no connection and no server for updates as previous email.Troubleshooting was performed, and the resolution was unknown.No harm requiring medical intervention was reported.It was unknown whether the customer will continue the use of the app, but the device will not be returned for analysis.
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Select patient information cannot be provided due to regional privacy regulations.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 employees 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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Search Alerts/Recalls
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