AMS 700 LGX? TENACIO? PUMP
Received Jan 5, 2026 · Event occurred Oct 1, 2025
Report 2124215-2026-00321 · MDR key 23959976
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100523127
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Male
- Post Operative Wound Infection
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH SWELLING AND A POSSIBLE INFECTION AT THE INCISION SITE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACED WITH A MALLEABLE DEVICE. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.