Model Number W1DR01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Discomfort (2330)
|
Event Date 02/06/2024 |
Event Type
Injury
|
Event Description
|
It was reported by the patient that post operative their heart rate is pounding out of their chest and is uncomfortable.The implantable pulse generator (ipg) was adjusted and remains in use. no further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was further reported that there was no issue with the ipg.It was determined that her heart valve was contributing to pounding on the patients chest.
|
|
Search Alerts/Recalls
|