AMS 700 LGX MS Pump
Received Jun 30, 2026 · Event occurred Jun 4, 2026
Report 2124215-2026-34864 · MDR key 25673425
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404251Catalog number
72404251
Lot number
1100626351
Product problems
- Inadequacy of Device Shape and/or Size
- Malposition of Device
Patient
74 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THE PUMP WAS POSITIONED CLOSE TO THE SHAFT WITH INSUFFICIENT TUBING. THE DEVICE WAS EXPLANTED AND REPLACED, AND A NEW PUMP WAS POSITIONED APPROPRIATELY WITHIN THE SCROTUM. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100786176. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).