Model Number 5076-52 |
Device Problems
Over-Sensing (1438); High Capture Threshold (3266)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/19/2024 |
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 that the right atrial (ra) lead exhibited a warning for high threshold.Far field r-wave (ffrw) oversensing was also observed on stored electrograms (egm).The lead is still in use.No patient complications have been reported as a result of this event.
|
|
Event Description
|
It was further reported that a subsequent remote transmission indicated that the ra lead was operating normally.
|
|
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
|