Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.Abbott has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Abbott defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2.Reference mfr report #: 1627487-2017-08680.It was reported that the patient developed an infection with pus at both incision and lead sites.Cultures were taken however the results are unknown at this time.As a result, the patient underwent surgical intervention (b)(6) 2017 to have their lead and ipg explanted.Reportedly, the patient was treated with antibiotics and was sent to the wound clinic.Patient is getting better.
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Event Description
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Device 2 of 2.Reference mfr report #: 1627487-2017-08680.Follow up revealed that the infection has just about been resolved and patient is doing very well now.
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Search Alerts/Recalls
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