AMS 700 LGX? TENACIO? PUMP
Received Jul 1, 2026 · Event occurred Jun 5, 2026
Report 2124215-2026-35134 · MDR key 25680078
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100810325
Product problems
- Inflation Problem
- Malposition of Device
- Migration
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTED INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY AND DISSATISFACTION IN MANIPULATING THE TENACIO PUMP. THE PATIENT INDICATED THAT, DUE TO ITS POSITION, HE WAS UNABLE TO ACHIEVE MORE THAN 50% INFLATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE TENACIO PUMP WAS EXPLANTED AND REPLACED WITH AN MS PUMP. ADDITIONALLY, IT WAS CONFIRMED THAT THE DIFFICULTY IN MANIPULATION WAS ASSOCIATED WITH PUMP MIGRATION AND MALPOSITION. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100856710, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4).