MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
|
Back to Search Results |
|
Model Number W1DR01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930)
|
Event Date 04/02/2024 |
Event Type
Injury
|
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 reported approximately two weeks post implant that the patient developed a pocket infection and that puss was coming out from the incision site.The ipg system was removed and replaced by a leadless implantable pulse generator (ipg). no further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary:the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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.
|
|
Search Alerts/Recalls
|
|
|