Model Number DM3500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Pocket Erosion (2013); Complaint, Ill-Defined (2331)
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Event Date 01/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 presented in clinic for routine follow up with complaints of soreness and stinging.It was observed that the implant site was red and irritated.The patient was treated with antibiotics.The patient presented in clinic again to synchronize the phone monitor to loop recorder.During this time, the implant site was also checked and it was noted that the loop recorder was slightly exposed.The device was explanted and the patient was stable post procedure.
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Event Description
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New information received states that the infection was suspected, and primary site of infection was determined to be an infected hair follicle in the vicinity of the implant site.The infection was related to extension of a purulent hair follicle and was not related to the device or procedure.Upon explant, incision site had healed, and device was not exposed.There was no erosion noted.
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Search Alerts/Recalls
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