Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Skin Erosion (2075)
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Event Date 08/13/2020 |
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 report number 1627487-2020-30735.It was reported that one of the leads eroded through the skin and causing the patient pain.No intervention is planned at this time.It is unknown which lead is related to the issue.Therefore, all the suspected devices are being reported.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Additional information indicated that a surgical intervention occured wherein the drg system was explanted.
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Search Alerts/Recalls
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