Model Number DM3500 |
Device Problems
Under-Sensing (1661); Decreased Sensitivity (2534)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that an asymptomatic patient presented remotely via merlin@home transmissions.Upon review, the patient's implantable cardiac monitor(icm) exhibited pause episodes due to under-sensing.Programming changes were recommended but not made.
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Event Description
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New information received stated that the implantable cardiac monitor continued to exhibit decreasing sensitivity.On (b)(6) 2019, the physician explanted the device and attempted to reimplant without the implant tool.The device again exhibited under-sensing.The physician then explanted and replaced the device successfully.There were no further adverse consequences to the patient.
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Manufacturer Narrative
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Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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