Model Number LNQ11 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: continuous monitoring after atrial fibrillation ablation: the linq af study.Europace (2018) 0, 1¿9.Doi:10.1093/europace/euy038.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 which contained information regarding implantable cardiac monitors (icms).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reports two patients developed a mild pocket haematoma and in one patient the device dislodged out of the pocket.The status of the devices is unknown.Further follow up did not yet yield any additional information.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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