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Model Number REPLY DR |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
Event Type
malfunction
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Event Description
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Reportedly, at incoming inspection level, it was observed that the implantation and explantation registration form was missing from the carton box of the subject pacemaker.
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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, at incoming inspection level, it was observed that the implantation and explantation registration form was missing from the carton box of the subject pacemaker.
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Search Alerts/Recalls
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