Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Skin Erosion (2075); Fluid Discharge (2686)
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Event Date 03/26/2024 |
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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It was reported that the patient's lead and anchor had eroded through the skin and fluid was present.As a result, surgical intervention took place on (b)(6) 2024 wherein the leads were secured at the anchor site to resolve the issue.Patient was admitted to the hospital and placed on iv antibiotics for observation, no infection was observed.It is unknown which lead or anchor eroded.
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Manufacturer Narrative
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The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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Manufacturer Narrative
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Correction: section d6a - the implant date should have been (b)(6) 2024 rather than (b)(6)2023.
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Event Description
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Related manufacturer report number: 1627487-2024-08964, 1627487-2024-08965.Additional information was received indicating the previous revision did not resolve the wound issue.The patient presented to the er on (b)(6) 2024 due to discomfort at the incision sites.As a result, additional intervention was undertaken on (b)(6) 2024 wherein the entire system was explanted.
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Search Alerts/Recalls
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