MEDTRONIC EUROPE SARL VIVA QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTBA2Q1 |
Device Problems
Mechanical Problem (1384); Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 cardiac resynchronization therapy defibrillator (crt-d) was being replaced for normal elective replacement indicator (eri).However, during the procedure, there was difficulty pulling out the left ventricular (lv) lead from the header.It was noted that there was blood in the electrode channel of the header.The device was explanted and replaced.It was also reported that the lv lead exhibited an insulation problem.The proximal rubber segment on which the lead serial number was located was supposed to not stay in place, but it came loose and was able to slide/move freely after the lead was pulled out of the header.The lead was assessed and was determined to be functioning appropriately.The freely movable part of the lead was fixed with a medical silicone adhesive and durable suture material.The lv lead remains in use.No 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.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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