Model Number 5076-58 |
Device Problems
Capturing Problem (2891); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that the right ventricular (rv) lead exhibited high threshold and rising threshold values since implantable pulse generator (ipg) change.The rv lead remains in use. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: w1dr01 implant date: (b)(6) 2022.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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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Event Description
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It was further reported, that the lead was reprogrammed.
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Search Alerts/Recalls
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