AMS 700 LGX? TENACIO? PUMP
Received Jan 2, 2026 · Event occurred Nov 1, 2025
Report 2124215-2026-00126 · MDR key 23946092
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100547750
Product problems
- Inflation Problem
- Inadequacy of Device Shape and/or Size
- Migration
Patient
59 YR · Male
- Discomfort
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE/PROCEDURE, AND IT IS NOTED AS SUCH AS IN THE INSTRUCTIONS FOR USE.
Description of Event or Problem
IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS HARD TO SQUEEZE AND HAD FLIPPED UPSIDE DOWN IN THE SCROTUM, CAUSING DISCOMFORT. THE PATIENT STATED HE WAS UNABLE TO FULLY INFLATE THE CYLINDERS. THE PHYSICIAN CONFIRMED THAT THE PUMP WAS DIFFICULT TO OPERATE, HAD FLIPPED UPSIDE DOWN IN THE SCROTUM, AND SUSPECTED THAT THE TUBING WAS TOO LONG. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.