Model Number DM3500 |
Device Problem
Migration (4003)
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Patient Problem
Complaint, Ill-Defined (2331)
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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 the patient alleged experiencing a shock/electrocution from their implantable cardiac monitor.The device is solely used as a diagnostic tool and not capable of providing therapy.The patient also suspected device migration.In clinic testing was unable to confirm device movement due to appropriate device sensing.No intervention was reported.The patient was stable.
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Event Description
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It was reported that the patient's implantable cardiac monitor was explanted on (b)(6) 2018.The patient was stable throughout.
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Manufacturer Narrative
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The reported field event of shock/electrocution was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.The icm is a low voltage monitoring device that has no capability of delivering a shock or electrocution sensation.
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Search Alerts/Recalls
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