Model Number PM3262 |
Device Problem
Pacemaker Found in Back-Up Mode (1440)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the pulse generator was in back-up mode pre-implant.About a month prior, a firmware upgrade was performed but was not in back-up at that time.The device was not used.
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Manufacturer Narrative
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The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a failed product code download.The device was tested on the bench and after reloading product code indicated normal device characteristics.
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Search Alerts/Recalls
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