AMS 700 MS PUMP
Received Jul 13, 2026 · Event occurred Jun 2, 2026
Report 2124215-2026-37456 · MDR key 25803793
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404310Catalog number
72404310
Lot number
1000258994
Product problems
- Mechanical Problem
- Material Puncture/Hole
Patient
71 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404293. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0187825002. MODEL/CATALOG DESCRIPTION: LGX 18CM SNAP FIT RT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000265327. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE PUMP CONNECTING TUBE WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.