AMS 700 LGX? TENACIO? PUMP
Received Dec 31, 2025 · Event occurred Dec 9, 2025
Report 2124215-2025-93996 · MDR key 23935716
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100523130
Product problems
- Inflation Problem
- Unintended Deflation
- Inflation Problem
- Unintended Deflation
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PUMP, TENACIO MODEL, EXHIBITED ISSUES WITH INFLATION AND MAINTAINING RIGIDITY. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE TENACIO PUMP WITH AN MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.