Model Number 5392 |
Device Problems
Nonstandard Device (1420); Failure to Power Up (1476); Device Displays Incorrect Message (2591)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/03/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.(b)(4).
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Event Description
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It was reported that the external pulse generator displayed an error code on startup.The epg is expected to be returned.There was no patient involvement.
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Manufacturer Narrative
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Product event summary: analysis confirmed the reported event, the main board was defective.As a result the main board was replaced.
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Event Description
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It was reported that the external pulse generator displayed an error code on startup.The epg was later returned.There was no patient involvement.
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Manufacturer Narrative
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Further analysis was performed on the main printed circuit board assembly.Visual inspection revealed no anomalies.Bench analysis found that after replacing the electrically erasable programmable read-only memory (eeprom) the device powered up normally.The device was run on the automated test console and all tests passed.Conclusion: confirmed the reported event, corrupted eeprom.
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Search Alerts/Recalls
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