MEDTRONIC SINGAPORE OPERATIONS LINQ II¿ INSERTABLE CARDIAC MONITOR; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
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Model Number LNQ22 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that during the implantable cardiac monitor (icm) implant procedure, the icm could not be connected to accessory equ ipment.Several accessory devices were attempted when trying to connect to the icm but were unsuccessful.The icm was removed. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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