Model Number W1SR01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Tachycardia (2095)
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Event Date 03/30/2024 |
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 the patients heart monitor showed their heart rate at zero during bed percussion therapy, though pacemaker spikes could be seen and pulse obtained.It was also noted that their heart rate would go to around one hundred and fifteen beats per minute during treatment and that the implantable pulse generator (ipg) may be responding to the treatment vibrations.The ipg remains in use. no further patient complications have been reported as a result of this event.
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Event Description
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It was further reported that there was no performance issues with the ipg.It was further noted patient symptoms not related to the performance of 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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