MEDTRONIC EUROPE SARL VIVA¿ QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTBA1QQ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Purulent Discharge (1812)
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Event Date 06/15/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient presented with a pocket infection that was positive for gram positive rods from an aspirate performed.It was also noted that a transesophageal echocardiogram (tee) showed vegetation on a lead.Upon opening the pocket, a large amount of purulent pus was expressed from the pocket.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted and a leadless implantable pulse generator (ipg) system was implanted.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: 459888 lead implanted: (b)(6) 2018; 6935m62.Lead implanted:
(b)(6) 2014; 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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It was reported that the patient presented with a pocket infection that was positive for gram positive rods from an aspirate performed.It was also noted that a transesophageal echocardiogram (tee) showed vegetation on a lead.Upon opening the pocket, a large amount of purulent pus was expressed from the pocket.The organism was identified as coagulase negative staphylococcus and bacillus species not anthracis or cereus.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted, and a leadless implantable pulse generator (ipg) system was implanted.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.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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