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

Model Number AMS 700 MS SERIES

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem Urinary Incontinence (4572)

Event Type  Injury  

Event Description

To: (b)(6), i am a (b)(6) year-old retired marine.This last (b)(6) 2020 i had two of your medical implants inserted.The first was the ams 800 urinary control system and the second was the ams 700 ms series penile prosthesis.I have had problems with both, that cause problems between my wife and i.Let's talk about the ams 800, which is great during the day, but when we begin to have intercourse, i would squirt urine and that is not pleasant for my wife.After the second time i tried to duplicate the squirting and was able to squirt in the shower and i was not excited at all.If the ams 800 was to control my urine, then it has failed, because before the ams 800 insertion, i did not squirt at all.The device was to stop leaks both day and night and it has not done that.Now, the ams 700 was to take care of my ed, which it has done somewhat.Both the ams 700 and 800 were activated on (b)(6) 2020.I have tried to pump up the ams 700 to a full erection.However, have only been able to get a partial erection.The bulb that i am supposed to squeeze to activate the device is as hard as a rock, and no matter and no matter how hard i try to squeeze the bulb, it will not squeeze at all.I have watched and read your information online that states that it will be easy to squeeze the device to obtain an erection with 10 to 25 pumps.The video shows that only two fingers can inflate the penis to full erection.However, i have not found this to be the case.I was hoping that the device would make my last years on earth wonderful with my wife, with all the problems taken care of.To contact me at home by email or phone or mail: (b)(6).Fda safety report id# (b)(4).

• Brand Name: PENILE PROTHESIS (AMS 700)
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10606061
• MDR Text Key: 209455714
• Report Number: MW5096963
• Device Sequence Number: 1
• Product Code: JCW
• 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: 09/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AMS 700 MS SERIES
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 93