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Model Number 29901A |
Device Problem
Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Event Description
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It was reported that the programmer repeatedly crashed during cardiovascular implantable electronic device (cied) follow-up sessions.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Product analysis: analysis was able to partially confirm the customer comment that the programmer repeatedly crashed during cardiovascular implantable electronic device (cied) follow-up sessions.Several interrogations were performed with implantable cardioverter defibrillator (icd), during the incoming inspection.No system crash was observed the programmer worked as expected, however several system errors were found in the log files.The software was re-installed and updated to the newest version as a preventative measure.The programmer passed all final functional and system tests.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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Search Alerts/Recalls
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