MEDTRONIC, INC. MEDTRONIC CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number MDT-CRT-D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446)
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Event Date 09/29/2022 |
Event Type
Death
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Select patient information cannot be included in regulatory report due to regional privacy regulations.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: impact of long-term optimizing atrioventricular delay using device-based algorithms on cardiac resynchronization therapy.Heart and vessels (2023) 38:216¿227.Doi: 10.1007/s00380-022-02162-4 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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Event Description
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Literature was reviewed regarding cardiac resynchronization therapy (crt) and optimizing atrioventricular delay.Patients were divided into responders versus non-responders.The authors described patient deaths; the causes of death were heart failure, arrhythmic deaths, bleeding, stroke, and unknown causes.There is no allegation of device-death relatedness indicated in the article; however, the device-relatedness has been requested, but not yet received.There were patients who experienced heart failure rehospitalizations; it is also unknown if the devices contributed to the heart failure.The status of the devices is unknown.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Event Description
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Additional information was received which indicated that there was no relatedness between the devices and the deaths or hf hospitalizations.
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Search Alerts/Recalls
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