AMERICAN MEDICAL SYSTEMS, INC AMS 700 MS SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-13 for AMERICAN MEDICAL SYSTEMS, INC AMS 700 MS SERIES manufactured by Ams.

Event Text Entries

[2935119] In (b)(6) 2010, i was implanted with the penile inflatable prosthesis [pump] ams 700 ms by dr. (b)(6) at (b)(6). However, it has never worked as promised: i experience pain every day since the operation, especially after sitting for over 30-45 minutes or when sleeping on one side, which is the only way i fall to sleep since childhood. So, while at the office, driving, traveling, movies, eating out, etc. I have pain in my private parts. At night, the pain wakes me up every 45-90 minutes, so i can't sleep well. Tissue or ligaments inside the scrotum is attached to the pump making it hard and painful to operate, which discourages me from having sex. When inflated, the penis glande [head] hurts even more, discouraging having sex. There is no significant or noticeable erection change; inflated or deflated, as promised in their brochures. See ams brochures in the internet. In their brochures, the erection is depicted from 0 to 130 degrees, approximately; while in real life, it remains at about 30-40 degrees deflated and when inflated barely moves up a few degrees (hardly noticeable as an erection). Penis size was reduced from 6 inches to about 4 inches in diameter, making it very difficult to have sex and embarrassing. The pipes reinforced with steel in the scrotum, pressure the skin outwards causing pain and disfigurement. The doctor said i need to go back to surgery to correct some of those problems, but the hospital requires that i pay another (b)(6), on top of the more than (b)(6) that i already paid in cash; and i think the pump just doesn't work as promised and the pain wouldn't go away, so i don't want to subject myself to another painful operation with no possibility of success. Please let me know if you can help since nobody warned me before the implant of all those serious problems and i am in pain 24/7. They are deceiving the consumers to induced them to have the implant when they know it doesn't work. They have a pts liaison webpage, but when i send them the above complaints, they just never replied. Alternatively, this may be just a one pt problem since even if no design defects are found in their product as a whole, the device i have may have been defective. In addition, they deceived me to induced me to have the surgery, which was extremely painful during recovery and now i have these options: leave it the way it is suffering pain almost all day and night and the other problems outlined above; replace it to correct some of the problems, but not the most important ones; or remove it and forget about intimacy for the rest of my life [i am (b)(6)]. Since the operation, i only had sex once and it was very difficult, painful, and embarrassing. Since then, i am discouraged to try it again or to even try to find a relationship with a women since i feel so bad and embarrassed. I will appreciate your help.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5026530
MDR Report Key2707874
Date Received2012-08-13
Date of Report2012-08-13
Date of Event2010-02-11
Date Added to Maude2012-08-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAMERICAN MEDICAL SYSTEMS, INC
Generic NameAMS 700 MS SERIES "PUMP"
Product CodeJCW
Date Received2012-08-13
Model NumberAMS 700 MS SERIES
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerAMS
Manufacturer Address10700 BREN RD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2012-08-13

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