MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
|
Back to Search Results |
|
Model Number W1DR01 |
Device Problem
Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/23/2024 |
Event Type
malfunction
|
Event Description
|
The device was returned to the manufacturer, analyzed, and tested out of specification.No 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 confirmed the failure and identified the root cause as a lack of adh esion between the insulator cup and the back shield.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.
|
|
Search Alerts/Recalls
|
|
|