Model Number LNQ11 |
Device Problems
Break (1069); Failure to Interrogate (1332); Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2019 |
Event Type
malfunction
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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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Event Description
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It was reported that during the implantable cardiac monitor (icm) implant procedure, the icm "popped out".It was further reported that the icm could not be interrogated and that the icm was bent.The icm was explanted and replaced.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.The returned device was damaged.The device was interrogated at the returned product analysis lab.The device could not be functionally tested due to damage sustained during the implant procedure.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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