MEDTRONIC PUERTO RICO OPERATIONS CO. 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 Problem
Cardiomyopathy (1764)
|
Event Date 03/20/2024 |
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 that the patient had been experiencing pacing-induced cardiomyopathy.The physician decided to upgrade the device for cardiac resynchronization pacing.During the procedure, when implanting the left ventricular (lv) lead, the lead exhibited no capture, high threshold and the lead could not be fixed/could not obtain a stable position.The lv lead implant was abandoned and a lead for left bundle branch pacing was implanted and successful cardiac resynchronization therapy was achieved via left bundle branch pacing.The device remains in use.No further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|