Model Number TEO SR |
Device Problem
Pacing Inadequately (1442)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2021 |
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 or approved by fda for marketing in the united states.
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Event Description
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Reportedly, after pocket closure while the patient was still in the operating room, and after the pacemaker was programmed with twin trace activated, the pacing rate went within 15 seconds from basic rate up to the max rate.
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Manufacturer Narrative
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D3 and g1 updated.Please refer to the attached analysis report.
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Event Description
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Reportedly, after pocket closure while the patient was still in the operating room, and after the pacemaker was programmed with twin trace activated, the pacing rate went within 15 seconds from basic rate up to the max rate.
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Search Alerts/Recalls
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