Model Number 5820 |
Device Problem
Data Problem (3196)
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Patient Problem
Fainting (1847)
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Event Date 11/14/2018 |
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 patient experienced presyncope after the device tripped elective replacement indicator (eri).Upon interrogation, battery characteristics noted that the eri trip was likely premature eri.Clearing the eri as well as reprogramming the base rate to a higher setting was discussed.No further information available.
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Event Description
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New information available on feb 4, 2019 states that, the device was explanted and replaced with a competitive product in (b)(6) 2018.No further information was available.
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Manufacturer Narrative
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The reported event of premature elective replacement indicator was not confirmed in the laboratory.The device was tested, and no anomalies were found.
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Search Alerts/Recalls
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