Model Number DM3500 |
Device Problem
Migration (4003)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 07/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient called in.Patient's original implanting physician at (b)(6) is dr.(b)(6).The patient was seen by dr.(b)(6) who initially confirmed the migration.Further information was requested but not received.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's app and implantable cardiac monitor (icm) were not working and had never worked.The patient wanted the device to be explanted.The patient presented for an in clinic visit and it was observed that the icm had migrated to the bottom of her breast close to her nipple.The physician at her current facility advised the patient to go to her original implanting physician to have the device explanted as it would require major surgery and he was unable to complete it.The device was at end of life (eos) and was awaiting explant.
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Event Description
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New information notes the implantable cardiac monitor was explanted and replaced.The patient was stable.
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Search Alerts/Recalls
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