MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 INFLATABLE PENILE PROSTHESIS; PROSTHESIS, PENIS, INFLATABLE

Device Problem Positioning Problem (3009)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994)

Event Date 09/06/2022

Event Type  Injury  

Event Description

I had a ams 700tm inflatable penile prosthesis implanted (b)(6) 2022.During the following week i was in extreme pain that got so intense i had to go to the er and receive some iv pain medication.It seems that my pump that was implanted into my scrotum was rubbing against the underside of my penis causing this intense pain.The rubbing had caused a large blood red bruise and sore to the touch spot on my scrotum.My urologist that performed the surgery told me to come see him the next business day which 4 days later because of labor day weekend.While at that appointment he deflated my penile implant and began pulling down on the pump in my scrotum, the pain was unbearable and i literally thought i would pass out from the pain he was causing pulling on the pump.His response to this was, "just take a deep breath", as he did this pulling 6 to 8 times during that visit.Deflating the implant did help with the pain of the pump rubbing on my penis, but there is no space between the top of the pump and the under side of my penis.This being said; as soon as i inflate it again the pump is going to be rubbing or digging into my penis causing great pain.When i do pull down on the pump as the doctor instructed, my penis pulls down as well.There is no slack to make the pump stay further down.My urologist blew off my concerns and said everything looks great and he would see me in 3 weeks.I am more than two weeks out and i am still having a considerable amount of pain.All the literature i read from boston scientific states that most pain gone after first week.I am still very bruised, that spot on my scrotum that had been so reddened is not as red, but still sore to touch.Can this be caused by the surgeon not leaving enough tubing length so that the pump is not literally next too or touching my penis? please let me know what way i should proceed, because it appears that my surgeon is not going to admit that something is not right.Fda safety report id# (b)(4).

• Brand Name: AMS 700 INFLATABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15418849
• MDR Text Key: 299967185
• Report Number: MW5112022
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Patient Sequence Number: 1
• Treatment: ASA 81MG; CERVICAL FUSION C3-6; CRESTOR ; CYMBLATA; EPIDURALS 3-4 TIMES A YEAR; FLOMAX; HCTZ; HYDROCODONE/TYLENOL; LASIX PRN; LISINOPRIL ; MEDICAL MARIJUANA 5%THC SOLUTION; MIGRAINE BOTOX INJECTIONS EVERY 3 MONTHS; PEPCID; PROPECIA; ROBAXIN; WELLBUTRIN ; ZYRTEC
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White