MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE S DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
|
Back to Search Results |
|
Model Number W3DR01 |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/14/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the implantable pulse generator (ipg) exhibited a data recording problem. the graph in the upper right hand corner of the quick look page did not produce.The ipg remains in use. no 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.
|
|
Event Description
|
It was further reported that there was no performance issue with the pacemaker.
|
|
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
|
|
|