HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Vomiting (2144); Dizziness (2194); Diaphoresis (2452)
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Event Date 05/03/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient was hospitalized for atrial fibrillation.The patient presented with light-headedness and vomiting and was receiving shocks from the implantable cardioverter defibrillator (icd).The patient reportedly felt flushed, hot, and diaphoretic prior to receiving a shock.A chest x-ray was performed.It was reported that the patient had a significant increase in alcohol consumption and the atrial fibrillation was considered alcohol induced.The patient was advised to reduce alcohol consumption and was discharged.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.This information was received from the mechanical circulatory support product surveillance registry study.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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Manufacturer Narrative
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A supplemental is being submitted for additional information.Additional information: - b5 desc evt problem: updated to include additional information regarding the resolved a-fib issue after the icd shock.Investigation of this event is pending and a supplemental report will be sent upon its completion.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 further reported that device interrogation showed episode of atrial fibrillation (a-fib) with rapid ventricular response (rvr) resolved following icd shock.
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Manufacturer Narrative
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A supplemental report is being submitted for investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received indicated that the patient was hospitalized for atrial fibrillation.The patient presented with light-headedness and vomiting and was receiving shocks from the implantable cardioverter defibrillator (icd).The patient reportedly felt flushed, hot, and diaphoretic prior to receiving a shock.A chest x-ray was performed.It was reported that the patient had a significant increase in alcohol consumption and the atrial fibrillation was considered alcohol induced.The patient was advised to reduce alcohol consumption and was discharged.It was further reported that device interrogation showed episode of atrial fibrillation (a-fib) with rapid ventricular response (rvr) resolved following icd shock.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of cardiac arrhythmia.Of note, the patient's reported medical history indicated the patient has a history of atrial fibrillation prior to implant.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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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