Model Number PLATINIUM SONR CRT-D 1811 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, during the review of some episodes, it was observed that two atps had zig-zags instead of straight lines.The slow vt atp1 is programmed as 'burst'.
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Event Description
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Reportedly, during the review of some episodes, it was observed that two atps had zig-zags instead of straight lines.The slow vt atp1 is programmed as 'burst'.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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