AMS 700 CX MS PUMP
Received Jul 21, 2026 · Event occurred Jun 22, 2026
Report 2124215-2026-39133 · MDR key 25892856
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100141344
Product problems
- Inflation Problem
- Material Puncture/Hole
Patient
64 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 A DEVICE THAT WOULD NOT INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED TEARS IN BOTH CYLINDERS. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS RETAINED AND USED WITH THE REPLACEMENT CYLINDERS AND PUMP. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100146784. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).