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 event only occurred with one patient but specific details on the patient were not provided.Without a lot number or device serial number, the manufacturing date cannot be determined.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: diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations.Annals of noninvasive electrocardiology.2021;00:e12864.Doi: 10.1111/anec.12864.If information is provided in the future, a supplemental report will be issued.
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