Model Number BOREA SR 1200 |
Device Problem
Pacemaker Found in Back-Up Mode (1440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2022 |
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 microport crm that was cleared or approved by fda for marketing in the united states.Preliminary analysis revealed that the reported event resulted from cross-talk disturbances.
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Event Description
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Reportedly, a borea pacemaker was interrogated with a smarttouch tablet in order to perform the 3.12 software upgrade, but a pop-up message appeared, indicating that the device was in stand-by mode and needed a reset.The reset was therefore performed, but then the upgrade could not be performed.In addition, it was indicated that the pacemaker was already reset 4 times.Preliminary analysis revealed that the reported event resulted from cross-talk disturbances.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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Reportedly, a borea pacemaker was interrogated with a smarttouch tablet in order to perform the 3.12 software upgrade, but a pop-up message appeared, indicating that the device was in stand-by mode and needed a reset.The reset was therefore performed, but then the upgrade could not be performed.In addition, it was indicated that the pacemaker was already reset 4 times.
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Search Alerts/Recalls
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