AMS 700 LGX? TENACIO? PUMP
Received May 16, 2025 · Event occurred Apr 29, 2025
Report 2124215-2025-31573 · MDR key 22035869
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100547772
Product problems
- Deflation Problem
- Unintended Deflation
- Deflation Problem
- Unintended Deflation
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 THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DEFLATION DURING INTERCOURSE WITH TENACIO PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS MICROSCOPICALLY INSPECTED, LEAK AND FUNCTIONALLY TESTED. THE PUMP PASSED VISUAL INSPECTION. NO DAMAGE OR ABNORMALITIES WERE FOUND. THE PUMP PASSED BOTH LEAKAGE AND FUNCTIONAL TEST. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED DEVICE ALLEGATION IS UNABLE TO BE CONFIRMED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DEFLATION DURING INTERCOURSE WITH TENACIO PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.