Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Pain (1994); Fluid Discharge (2686)
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Event Date 03/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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:1627487-2020-03972.It was reported that the patient's lead became exposed at the incision site.As a result, surgical intervention was undertaken (b)(6) 2020 wherein the lead was buried and the wound re-sutured.Following the procedure on (b)(6) 2020, the patient was experiencing increased pain and fluid at the incision site.It is unknown which lead became exposed.Therefore, both leads are being reported.
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Event Description
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Additional information indicates surgical intervention was undertaken on (b)(6) 2020 wherein the left lead was explanted.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.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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