Model Number 5156 |
Device Problem
Difficult to Interrogate (1331)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2018 |
Event Type
Injury
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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 intermittent interrogation of the device was observed.The device was near eri and may have contributed to the issue.The patient was fine before, during, and after the interrogation.The device was explanted and replaced.
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Event Description
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New information received notes that the patient was stable before, during, and after the procedure.
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Search Alerts/Recalls
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