AMS 700 CXR
Received Jul 20, 2026 · Event occurred May 19, 2026
Report 2124215-2026-38769 · MDR key 25880690
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404012Catalog number
72404012
Lot number
1100078969
Product problems
- Mechanical Problem
Patient
61 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100257141. MODEL/CATALOG DESCRIPTION: PUMP MS. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000337774. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY AND WAS NOT MAINTAINING NORMAL PRESSURIZATION. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.