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Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Discomfort (2330)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: "implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation." health technology assessment.2020.24(5): v-184.Doi: 10.3310/hta24050.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed that contained information regarding implantable cardiac monitors (icm) to detect atrial fibrillation (af) after cryptogenic stroke.Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reports patients implanted with icms that experienced pain, skin reactions, infection, and pocket erosion which led to device removal.The status/ disposition of the devices is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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Search Alerts/Recalls
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