Model Number 5392 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/17/2018 |
Event Type
malfunction
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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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Event Description
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It was reported that the measured output of the external pulse generator (epg) was lower than the programmed output.The caller was advised to return the epg for service, however the current status is unknown.There was no patient involvement.
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Manufacturer Narrative
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Product event summary: manufacturer's analysis was unable to confirm the customer comments that the external pulse generator (epg) output was lower than the programmer output.The epg passed all incoming functional testing; the main board was replaced as a preventive measure.The device passed all final functional 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 further reported that the epg has been returned.
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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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