Model Number 5392 |
Device Problems
Failure to Power Up (1476); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/30/2015 |
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 (epg) displayed an error on startup, before use with a patient.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 device failed functional testing, the main board was defective.It was also noted that the upper case was broken.
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Event Description
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It was reported that the external pulse generator (epg) displayed an error on startup, before use with a patient.The epg was later returned to the manufacturer for servicing.There was no patient involvement.
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Search Alerts/Recalls
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