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Model Number ORCHESTRA PLUS |
Device Problem
Loss of Data (2903)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/07/2015 |
Event Type
malfunction
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Event Description
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Reportedly, the programmer software was upgraded (version 2.44j) on (b)(6) 2015.However some data were missing after the upgrade.On (b)(6) 2015, the programmer was checked again and the patient data of several models were missing on the programmer (reply200, paradym, paradym2 and ovatio); whereas the programmer files of some other models were available on the programmer (symphony, sole, reply, etc).An analysis is requested.Preliminary analysis showed that the loss of data is a consequence of a sudden shutdown of the machine that happened during the step of database saving.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Reportedly, the programmer software was upgraded (version (b)(4)) on (b)(6) 2015.However some data were missing after the upgrade.On (b)(6) 2015, the programmer was checked again and the patient data of several models were missing on the programmer (reply200, paradym, paradym2 and ovatio); whereas the programmer files of some other models were available on the programmer (symphony, sole, reply, etc).An analysis is requested.Preliminary analysis showed that the loss of data is a consequence of a sudden shutdown of the machine that happened during the step of database saving.
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Search Alerts/Recalls
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