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 04/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer report number: 1627487-2023-02293, 1627487-2023-02294.It was reported that the patient experienced an infection at the ipg and lead sites due to poor wound healing.The patient was prescribed antibiotics and is being monitored by a physician, follow up indicated the wounds are healing.
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Event Description
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Additional information was received that the patient's system was explanted.
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Manufacturer Narrative
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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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