Model Number G148 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) displayed an alert indicating it was in safety core after an interrogation.The alert was indicative of a memory error and a device replacement was recommended.The device was then explanted and replaced successfully.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
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Event Description
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This report is being filed to provide the results of device analysis.
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Search Alerts/Recalls
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