MEDTRONIC EUROPE SARL CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
|
Back to Search Results |
|
Model Number DTMA2QQ |
Device Problems
Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
|
Patient Problem
Shock from Patient Lead(s) (3162)
|
Event Date 03/18/2024 |
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 received possible inappropriate anti-tachycardia pacing therapy and high voltage therapy for atrial fibrillation (af) with aberrancy that the cardiac resynchronization therapy defibrillator (crt-d) classified as ventricular fibrillation (vf).The crt-d remains in use.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.Analysis of the device memory had an observ ation relating to the at/af detection.The device memory indicated an unexpected anti-tachycardia pacingtherapy.Anti-tachycardia pacing.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 further reported that the patient was given medication.
|
|
Search Alerts/Recalls
|
|
|