MS PUMP
Received Jul 14, 2026 · Event occurred Jun 18, 2026
Report 2124215-2026-37827 · MDR key 25820424
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404209Catalog number
72404209
Lot number
1100868425
Product problems
- Fluid/Blood Leak
- Inflation Problem
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100910461. 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) PRESENTED WITH AN INABILITY TO INFLATE THE DEVICE. DURING REVISION SURGERY, THE PHYSICIAN IDENTIFIED A LEAK IN THE CYLINDERS; THEREFORE, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.