Model Number 503452 |
Device Problems
Electrical /Electronic Property Problem (1198); High impedance (1291); Under-Sensing (1661); Capturing Problem (2891); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Event Description
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It was reported that the right ventricular (rv) lead exhibited a high impedance measurement resulting in a polarity switch.A slight decrease in impedance was also noted in addition to undersensing.The lead remains in use. no patient complications have been reported as a result of this event.It was additionally reported that ventricular capture could not be confirmed.
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Manufacturer Narrative
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Correction: b5; h6 device codes (fdd/annex a).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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Continuation of d10: 429678 lead implanted (b)(6) 2017; 553445 lead implanted 05-apr-2000.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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Event Description
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It was reported that the right ventricular (rv) lead exhibited a high impedance measurement resulting in a polarity switch.A slight decrease in impedance was also noted in addition to undersensing.The lead remains in use. no patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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