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Model Number 5392 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: the error was confirmed.The issue was attributed to the main printed circuit board (pcb) being out of electrical specification, due to contamination.Further contamination was found throughout the interior of the epg and underneath the encoder knobs.The hanger assembly was damaged.All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested and it passed its final quality assurance tests.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the external pulse generator (epg) presented an error code, which was unable to be cleared.The epg was returned for service.There was no patient involvement.On 2018-07-15: the programmer tested out of specification during manufacturer's analysis.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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