Model Number 5392 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: analysis found that the device failed over voltage current drain functional testing.The device was mechanically intact.The unit was calibrated and tested and passed testing.A good faith effort will be made to obtain the applicable information relevant to the report.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 device was defective however no further details were available.The external pulse generator (epg) was returned for servicing.There was no patient involvement.
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Manufacturer Narrative
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Further review prompted a change in the device analysis results.The change is reflected in this report under conclusion code(s) and result code(s).Investigation determined that there was no device failure, but rather an issue with the tester used during functional testing.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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