Model Number 106524US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Atrial Fibrillation (1729); Pleural Effusion (2010); Tachycardia (2095)
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Event Date 07/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient experienced a implantable cardioverter-defibrillator (icd) shock for atrial fibrillation with rapid ventricular response on (b)(6) 2021.The patient had a history of these issues and was started on amiodarone by drops.Cardioversion was also done and the patient was stable at the time.The patient experienced bilateral pleural effusions which were seen in chest x-ray on (b)(6) 2021.They had a moderate left and a small right pleural effusion.The patient remained in ongoing/stable condition.
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Event Description
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The patient's rapid ventricular response deteriorated into ventricular tachycardia.The patient was noted to have atrial fibrillation and implantable cardioverter-defibrillator prior to left ventricular assist device.The patient was discharged on (b)(6) 2021 on amiodarone 200 milligrams per day.An electrocardiogram on (b)(6) 2021 showed that the patient was in v-paced rhythm and biventricular pacemaker was detected.No further events were noted.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between the device and the reported cardiac arrhythmia and pleural effusions could not be conclusively established through this investigation.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2021.The heartmate 3 left ventricular assist system instructions for use lists cardiac arrhythmia as an adverse event, as well as a potential late postimplant complication that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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