AMS 700 LGX? TENACIO? PUMP
Received Jul 20, 2026 · Event occurred Jun 22, 2026
Report 2124215-2026-38778 · MDR key 25876879
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100701255
Product problems
- Deflation Problem
- Inflation Problem
- Material Deformation
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO PROPERLY INFLATE AND DEFLATE THE DEVICE PUMP MECHANISM. UPON INSPECTION, A KINK IN THE TUBING BETWEEN THE PUMP AND THE RESERVOIR WAS IDENTIFIED. AS A RESULT, THE CYLINDERS WERE EXPLANTED, AND THE EXISTING RESERVOIR WAS DRAINED AND RETAINED. A COMPLETE NEW DEVICE SYSTEM WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100685087. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).