MEDTRONIC EUROPE SARL COBALT¿ XT HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPA2D4 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Dyspnea (1816); Tachycardia (2095); Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)
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Event Date 08/26/2023 |
Event Type
Death
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Event Description
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It was reported that the patient presented to the emergency department for dyspnea due to heart failure and was hospitalized for treatment.Approximately three weeks later during upgrade to a cardiac resynchronization therapy defibrillator (crt-d) system there was difficulty in accessing the patient¿s vein therefore the left ventricular (lv) lead was placed epicardially via thoracotomy.On the night following the upgrade procedure, the patient¿s condition suddenly changed and cardiopulmonary resuscitation (cpr) was performed.The electrocardiogram noted the patient¿s rhythm progressed from a tachycardic atrial fibrillation (af) to ventricular tachycardia (vt)to ventricular fibrillation (vf) requiring anti-tachycardia pacing (atp) and high voltage therapy.Ventricular tachycardia/ ventricular fibrillation (vt/vf) recurred several times and external cardioversion was performed.Cardiac massage was performed for more than one hour and the patient¿s condition became stable.Approximately three days later, at a crt-d check, the physician determined that therapeutic intervention was needed for the af and both cardioversion and atp were administered.Subsequently, vt/vf occurred frequently five days later developed into an arrhythmic storm.High voltage therapy was provided via the crtd and external defibrillation but was unable to terminate the arrhythmia and the patient passed away.The cause of death was provided as heart failure.
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Manufacturer Narrative
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Continuation of d10: 4968-35 lead, implanted: on (b)(6) 2023.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Correction: h6 eval code conclusion (fdc/annex d).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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 was performed and no anomalies were found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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