Model Number 5076-58 |
Device Problems
Intermittent Capture (1080); High impedance (1291); Capturing Problem (2891); High Capture Threshold (3266)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/28/2024 |
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 one day post implant the right ventricular (rv) lead was revised due to intermittent capture.High bipolar threshold and a lead warning for high undefined impedance were noted during the revision procedure.Following this, the lead exhibited rising thresholds.The lead was reprogrammed and remains in use. no patient complications have been reported as a result of this event.
|
|
Event Description
|
It was further reported that the rv lead was explanted and replaced.
|
|
Manufacturer Narrative
|
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated right ventricular undersensing.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.Analysis of the device memory indicated pacing capture threshold in the right ventricle was rising.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
|