It was reported that the patient stated that he was implanted with device approximately 3 months ago, and everything had been working fine until past few days.He further reported that he has an urge to pee but when he cycles his device, he is unable to void.Boston scientific patient service specialist discussed proper activation/deactivation with the patient, and it does not appear that he is deactivated.The patient was suggested to reach out to his physician.No further information was provided.
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B3.Actual event date is unknown.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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