Model Number DM3500 |
Device Problems
Migration or Expulsion of Device (1395); Under-Sensing (1661)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/08/2018 |
Event Type
malfunction
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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 the patient presented remotely via merlin.Net transmission with undersensing anomaly observed on the implantable cardiac monitor; device manipulation in the pocket was suspected.No programming modifications were performed.The patient would continue to be monitored remotely.
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Event Description
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New information received notes that an episode of false pause due to undersensing was noted on the device.No further information was reported.
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Event Description
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New information received notes a recurrence of a false pause episode caused by what is suspected to be migration of the device causing undersensing, which is leading to false pauses.It was discussed that isometric testing would be performed.No further information was reported.
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Search Alerts/Recalls
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