MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
|
Back to Search Results |
|
Model Number W1DR01 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/03/2024 |
Event Type
malfunction
|
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 ten weeks post implant that the right ventricular (rv) lead exhibited high thresholds.It was further reported that two months post implant prior high thresholds noted, patient experienced complete heart block.Device check showed loss of capture.It was further reported that the there was a loose set screw.The rv lead was initially reprogrammed and then lead was revised.The implantable pulse generator (ipg) remains in use.High thresholds were noted post operatively.Physician commented at next device check that although thresholds high post lead revision, remained stable.No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|