MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVEAL PLUS; RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
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Model Number 9526 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Erosion (1750); Death (1802); Unspecified Infection (1930)
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Event Date 10/04/2013 |
Event Type
Death
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Event Description
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A journal article was reviewed which contained information regarding this implantable loop recorder (ilr).The article included the following failure modes: deaths, erosion, infection, and device "malfunction." information obtained through follow up indicated that this patient had expired.There was no cause of death available.No further information was provided.
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Manufacturer Narrative
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This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.If additional relevant information is received, a supplemental report will be submitted.There is no information given as to the exact date of death for the patient; therefore, the date of death included in this report is purely an estimate.Patient information is limited due to confidentiality concerns.Referenced article: implantable loop recorder allows an etiologic diagnosis in one-third of patients - results of the spanish reveal registry.Circ.J.2013;77(10):2535-2541.(b)(4).
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