AMS 700 SPHERICAL RESERVOIR
Received Jul 7, 2026 · Event occurred May 13, 2026
Report 2124215-2026-36264 · MDR key 25733143
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404156Catalog number
72404156
Lot number
1100699923
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Pain
- Paralysis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED POSTOPERATIVE PAIN AND WAS UNABLE TO MOVE HIS LEGS. UPON INSPECTION, THE RESERVOIR WAS FOUND TO BE COMPRESSING THE FEMORAL NERVE. AS A RESULT, THE RESERVOIR WAS EXPLANTED AND REPLACED ON THE LEFT SIDE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404238. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100759784. MODEL/CATALOG DESCRIPTION: PUMP AND CYLINDER. UNIQUE IDENTIFIER (UDI) #: (B)(4).