AMS 700 CX MS Pump
Received Jun 30, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-35012 · MDR key 25673618
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404237Catalog number
72404237
Lot number
1100287304
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Unspecified Infection
- Pain
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100358446. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. INFECTION AND PAIN ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOMS OF INFECTION AND PAIN ARE KNOWN RISKS ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN IN THE SCROTAL AREA. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A SEMI RIGID PENILE PROSTHESIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.