Model Number TEO DR |
Device Problem
Pacing Inadequately (1442)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
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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During a replacement of a pacemaker dependent patient, the subject pacemaker device allowed a pause, reportedly around 6 to 8s, after completely screwing the screw and hearing the characteristic clicks of the screwdriver.
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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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During a replacement of a pacemaker dependent patient, the subject pacemaker device allowed a pause, reportedly around 6 to 8s, after completely screwing the screw and hearing the characteristic clicks of the screwdriver.
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Search Alerts/Recalls
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