Model Number DM3500 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the patient was having their implantable cardiac monitor removed.During the procedure, the header snapped off.The physician used foreceps to explant.There were no adverse effects to the patient due to this.
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Manufacturer Narrative
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The reported field event of a broken header was confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.The damage found was sustained during the surgical procedure.
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Search Alerts/Recalls
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