InjuryJCW
AMS 700 LGX MS PUMP
Received Jul 17, 2026 · Event occurred Jul 1, 2024
Report 2124215-2026-38624 · MDR key 25864087
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404252Catalog number
72404252
Lot number
1100038611
Product problems
- Inflation Problem
- Mechanical Problem
- Failure to Deflate
Patient
73 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000307740. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE AND DIFFICULTY INFLATING AND DEFLATING THE DEVICE SINCE IMPLANTATION. A REVISION SURGERY WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.