Model Number 459888 |
Device Problem
High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: 5076-52 lead, implanted: (b)(6) 2007.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 reported that during use of the left ventricular (lv) lead, an alert triggered for impedance that was noted to be higher than the programmed threshold. the lv lead impedance threshold was re-programmed and the 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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Correction: b1.Adv event/prod prob, h1.Type of reportable event, removal of imf (annex f) health impact code f12, f2307.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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