Model Number DM3500 |
Device Problems
Display or Visual Feedback Problem (1184); Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/12/2019 |
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 during interrogation of device following implant, an error message was noted.The device settings were restored, device was interrogated and paired successfully.No adverse events occurred.Patient was stable and was discharged soon after.
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Event Description
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New information received notes that the device had been exposed to cold temperature which temporarily brought the voltage low enough to look like a depleted battery.Device firmware was downloaded to reset condition and everything was normal after that.
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Search Alerts/Recalls
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