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Model Number TEO DR |
Device Problem
Missing Test Results (3267)
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Patient Problem
No Information (3190)
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Event Date 10/22/2019 |
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 unites 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, on (b)(6) 2019, during a follow-up after the implantation of the subject device, tests were performed but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On (b)(6) 2019, when checking the recorded interrogation files, it was suspected that the aforementioned data were not saved.The tests were performed manually and the event occurred with two orchestra programmers.
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Event Description
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Reportedly, during the follow-up after the implantation of the subject device on (b)(6) 2019, tests were performed manually but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On 18 november 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the aforementioned data were not saved.
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Event Description
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Reportedly, during the follow-up after the implantation of the subject device on (b)(6)2019, tests were performed manually but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On (b)(6) 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the aforementioned data were not saved.
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Manufacturer Narrative
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Preliminary analysis results showed that the device behaved as specified.B3 was modified: the correct event date is (b)(6) 2019.B5 was corrected accordingly.
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Search Alerts/Recalls
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