It was reported that the patient, with an inflatable penile prosthesis (ipp), presented with severe abdominal pain and the pump was not working properly.It was found that the reservoir had adhered to the iliac vein.The pump and reservoir were explanted, and the cylinders were capped and surgically abandoned.At an unspecified point of the procedure, the patient was admitted to the intensive care unit.There were no additional patient complications reported and it was noted that the patient is expected to recover.
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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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