Catalog Number 9-ASD-015 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Fatigue (1849); Headache (1880); Movement Disorder (4412)
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Event Date 01/18/2024 |
Event Type
malfunction
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Event Description
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The article, "headaches in children after transcatheter device closure of atrial septal defects: a single centre experience", was reviewed.The article presented a case study of a 5-year-old, 16.5 kg, female patient with a fenestrated atrial septal defect.It was reported that on an unknown date, a 15mm amplatzer septal occluder was implanted.A small residual shunt was noted during procedure.It was then reported shortly after procedure, the patient developed dizziness and fatigue.Magnetic resonance imaging (mri) was performed, however, results were normal and non-pathologic.The patient later described experiencing headaches, gradually improving but still documented several years after the procedure.The article concluded that the study suggested a minimal estimate of 15% as the incidence of headache in children who undergo tdc.This estimate can inform counseling prior to tdc.Determination of the true incidence will require focused prospective data collection.[(b)(6)].
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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As reported in a research article, "headaches in children after transcatheter device closure of atrial septal defects: a single centre experience", on an unknown date, a 15mm amplatzer septal occluder was implanted in a 5-year-old, 16.5 kg, female patient with a fenestrated atrial septal defect.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Peri- and post-procedural complications included dizziness (movement disorder), fatigue, headaches, residual shunt.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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