Model Number 5392 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/31/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis found the main printed circuit board assembly was out of electrical specification.(b)(4).
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Event Description
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The external pulse generator was returned to the manufacturer, analyzed and tested out of specification.No patient involvement or complications were reported.
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Manufacturer Narrative
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Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that all testing passed.The error log did not indicate any errors.Conclusion: the finding found during service and repair of the device could not be confirmed.
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Search Alerts/Recalls
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