Model Number DM3500 |
Device Problems
Difficult to Interrogate (1331); Failure to Interrogate (1332); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information was requested but not received.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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During an in-clinic follow up, the device could not be interrogated.No intervention has been conducted.The patient was stable and will continue to be monitored.
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Event Description
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During an in-clinic follow up, it was noted that the device interrogation was slow and that some of the electrogram readings obtained were invalid.No intervention has been conducted at this time.The patient was stable and will continue to be monitored.
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Search Alerts/Recalls
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