MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number W1DR01 |
Device Problem
Pacing Problem (1439)
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Patient Problem
Bradycardia (1751)
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Event Date 04/18/2024 |
Event Type
malfunction
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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 reported that one month post implant patient experienced a heart rate in the forties in beats per minute per monitor.The right ventricular (rv) lead exhibited a micro-dislodgement with high thresholds, possible intermittent loss of capture on current elect rograms (egm) resulting in v-v intervals below the programmed lower rate.The implantable pulse generator (ipg) did not appear to be working.The ipg remains in use.The rv lead was explanted and replaced. no further patient complications have been reported as a r esult 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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Event Description
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It was further reported that there was no performance issues with the ipg.
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Search Alerts/Recalls
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