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Model Number 5392 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); No Device Output (1435); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).
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Event Description
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It was reported that the external pulse generator (epg) attempted to be used on a patient, but since the epg was stored with the battery removed per instructions for use, there was no output.Another epg was used instead.The status of the epg is unknown.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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