MEDTRONIC SINGAPORE OPERATIONS AZURE S DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number W3DR01 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Dyspnea (1816)
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Event Date 03/14/2024 |
Event Type
malfunction
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Event Description
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It was reported that the patient experienced more shortness of breath on exertion and was feeling worse since implant.It was also reported that the right ventricular (rv) lead exhibited oversensing of noise resulting in pacing inhibition and high and undefined impedance warnings which were suspected to be indicative of a possible connection issue with the implantable pulse generator (ipg).The ipg and rv lead remain in use. no 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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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory had an observation relating to pacing.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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