AMS 700 LGX? TENACIO? PUMP
Received Sep 22, 2025 · Event occurred Dec 12, 2024
Report 2124215-2025-64903 · MDR key 23116670
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100569644
Product problems
- Inflation Problem
- Failure to Deflate
- Inflation Problem
- Failure to Deflate
Patient
54 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INABILITY TO EASILY INFLATE AND DEFLATE THE DEVICE. PATIENT UNDERWENT A REPLACEMENT SURGERY DURING WHICH THE PHYSICIAN REPLACED THE TENACIO PUMP WITH AN MS PUMP. THE PHYSICIAN NOTED THAT THE PATIENT HAD TESTICULAR PAIN AND REQUESTED HIS TESTICLE BE REMOVED AND STATED THAT THE TESTICULAR PAIN WAS UNRELATED TO THE PUMP. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).