AMS 700 CX MS PUMP
Received Jul 3, 2026 · Event occurred Apr 1, 2026
Report 2124215-2026-35820 · MDR key 25704825
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404238Catalog number
72404238
Lot number
1100746584
Product problems
- Migration
Patient
64 YR · Male
- Deformity/ Disfigurement
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS FUNCTIONING PROPERLY; HOWEVER, A SLIGHT UNEXPECTED CURVATURE WAS OBSERVED. UPON EVALUATION BY THE UROLOGIST, A PROXIMAL CROSSOVER WAS DIAGNOSED. A CORRECTIVE SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE CROSSOVER CYLINDER WAS PARTIALLY REMOVED, THE AFFECTED CORPORAL BODY WAS DILATED CORRECTLY, AND THE SAME CYLINDER INSERTED BACK IN. NO ADDITIONAL DEVICE ISSUES WERE IDENTIFIED, AND NO PATIENT COMPLICATIONS WERE REPORTED.