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Model Number 9529 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Dyspnea (1816); Shock (2072); Impaired Healing (2378)
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Event Date 02/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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This information is based entirely on journal literature.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 gender of the baseline characteristics is male and the baseline age is 71 years old.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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article:baseline demographics, safety, and patient acceptance of an insertable cardiac monitor for atrial fibrillation screening: the reveal-af study.Journal of atrial fibrillation.2017; 9(5).A good faith effort will be made to obtain the applicable information relevant to the report.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.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 that there were adverse events including device migration/ site erosion, impaired healing, shock/dyspnea, insertion site pain, and oversensing requiring repositioning of the device.The status of the device 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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Search Alerts/Recalls
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