Model Number KORA 250 SR |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device model involved in this mdr 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.
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Event Description
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The subject device implanted in (b)(6) 2016 was explanted in (b)(6) 2021, reportedly due to premature battery depletion.
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Event Description
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The subject device implanted in (b)(6) 2016 was explanted in (b)(6) 2021, reportedly due to premature battery depletion.
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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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