InjuryJCW
AMS 700 LGX MS PUMP
Received Jul 15, 2026 · Event occurred Jun 29, 2026
Report 2124215-2026-38037 · MDR key 25829198
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404253Catalog number
72404253
Lot number
1100624194
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) LOST FUNCTIONAL EFFICACY AND HAD INADEQUATE PERFORMANCE. DURING A CLINIC OFFICE VISIT NON-INVASIVE TROUBLESHOOTING WAS ATTEMPTED INCLUDING MANUAL MANIPULATION OF THE PUMP WITH NO SUCCESS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.