MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
|
Back to Search Results |
|
Model Number W1DR01 |
Device Problem
False Alarm (1013)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/17/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that there was a false low impedance warning on carelink for the right ventricular (rv) his bundle lead.It was reported that the rv his bundle lead exhibited undersensing and unnecessary atrial and ventricular pacing.It was reported that the right atrial (ra) lead exhibited falling impedance, unstable thresholds and diminished sensing.It was also reported that the ra lead exhibited oversensing and noise resulting in false determination of atrial tachycardia/atrial fibrillation (at/af) episodes.The implantable pulse generator (ipg), rv his bundle lead and ra lead remain in use. no patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Continuation of d10: 310c27 valve implanted on (b)(6) 2020 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
|
|
|