AMS 700 LGX? TENACIO? PUMP
Received Jul 3, 2026 · Event occurred Apr 1, 2026
Report 2124215-2026-35809 · MDR key 25704815
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404453Catalog number
72404453
Lot number
1100547613
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Erosion
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100591946 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE PUMP AT THE SCROTUM. THE EROSION WAS SUSPECTED TO HAVE BEEN CAUSED BY PRESSURE; HOWEVER, IT WAS NOT CONFIRMED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP WITH A TACTRA DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.