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Model Number KORA 250 DR |
Device Problem
Data Problem (3196)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
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 and approved by fda for marketing in the united states.
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Event Description
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Reportedly, it was observed upon interrogation of the subject pacemaker that the content of the device memories (statistics, lead measurements data,.) was empty.
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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, it was observed upon interrogation of the subject pacemaker that the content of the device memories (statistics, lead measurements data,.) was empty.
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Search Alerts/Recalls
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