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Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Erectile Dysfunction (4511)
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Event Date 04/30/2021 |
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 1627487-2021-13959.Related manufacturer report 1627487-2021-13960.It was reported that patient experienced genitourinary side effects, testicular pain, difficulty getting an erection and inconsistence.Patient saw an urologist and was cleared of any gu issues.The device therapy was turned off for two months and continued to have testicular pain.The device system was explanted, and a new device system was explanted.There were no complications during the procedure.Patient was stable.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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