MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number W1DR01 |
Device Problems
Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
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Patient Problem
Tachycardia (2095)
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Event Date 01/30/2024 |
Event Type
Injury
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Event Description
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It was reported that approximately two weeks post implant the patient experienced atrial tachycardia with rapid heart rate.The implantable pulse generator (ipg) exhibited a loose set screw and a polarity switch.The right atrial (ra) lead exhibited oversensing, noise and high out of range (oor) impedance.A revision was completed to fix the loose set screw.The ipg and ra lead remains in use.No further patient complications have been reported as a result of this .
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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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Correction to b5, h6 a07 removed 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 polarity switch occurred on th ra lead not the ipg.
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Search Alerts/Recalls
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