Model Number 3664 |
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 Date 08/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is unknown.Information requested, but not yet received.
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Event Description
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It was reported that the patient presented with oozing coming out of the incision by the battery.In an updated from (b)(6) 2023, it was reported that the oozing had stopped.On (b)(6) 2023, it was reported that the patient's body rejected the implant and, as a result, surgical intervention was undertaken wherein the drg system was explanted at an unknown date to address the issue.No other information is known at this time.
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Manufacturer Narrative
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During processing of this incident, attempts were made to obtain complete event information.A suspected infection was reported to abbott.It was determined the patient presented oozing coming out of the incision by the ipg.The reported oozing stopped.The patient's body rejected the implant and, the drg system was explanted at an unknown date to address the issue.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.
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Search Alerts/Recalls
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