Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Seroma (2069); Fluid Discharge (2686)
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Event Date 07/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient's weight, but the information was not received.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number 3006705815-2019-02701, 1627487-2019-08497.It was reported that a fluid discharge was found at the ipg pocket site.Patient went to the emergency room where an abscess was found at l2-l3.A seroma was later confirmed via x-rays and patient was treated with oral antibiotics.Physician later indicated that no signs of infection were present.The fluid was drained in the doctor¿s office.The issue was resolved.
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Manufacturer Narrative
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The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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