Model Number DM2102 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 insertable cardiac monitor exhibited premature elective replacement indicator.No intervention was performed.No further information was available.
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Manufacturer Narrative
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Upon review, the insertable cardiac monitor should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
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Search Alerts/Recalls
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