Model Number W1DR01 |
Device Problem
Pacing Problem (1439)
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Patient Problem
Bradycardia (1751)
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Event Date 04/19/2024 |
Event Type
malfunction
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Event Description
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It was reported three days post implant that the patient stated they experienced bradycardia and a heart rate below than the lower rate limit of the implantable pulse generator (ipg).The patient stated they "noticed their phone was in their front shirt pocket over the device and removed it" and their "pulse went up to sixty beats per minute." the patient asked if magnetic interference could be causing the low heart rate. the ipg remains in use. no further patient complications have been reported as a result 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 reproted that normal function was noted on the ipg.
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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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Search Alerts/Recalls
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