inforMED
InjuryJCW

AMS 700 LGX TENACIO PUMP

Received Dec 11, 2024 · Event occurred Nov 22, 2024

Report 2124215-2024-78313 · MDR key 20904118

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404453

Catalog number

72404453

Lot number

1100523972

Product problems

  • Deflation Problem
  • Inflation Problem
  • Mechanical Problem
  • Malposition of Device
  • Migration
  • Deflation Problem
  • Inflation Problem
  • Mechanical Problem
  • Malposition of Device
  • Migration

Patient

74 YR · Unknown

  • Discomfort
  • Discomfort

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HE HAS BEEN RECENTLY IMPLANTED AND TRAINED BUT IS UNABLE TO INFLATE OR DEFLATE THE DEVICE DUE TO THE HIGH POSITIONING OF THE PUMP. HE STATED THAT IT IS ALSO VERY UNCOMFORTABLE AS IT PRESSES AGAIN THE BASE OF HIS SHAFT AND IS VISIBLE THROUGH CLOTHING. HE STATED HE DID DISCUSS THIS WITH HIS DOCTOR, WHO STATED IT COULD NOT BE MANIPULATED OUTSIDE SURGERY IF AT ALL AND WAS OFFERED TACTRA AS POTENTIAL OPTION. PATIENT STATED THAT WHEN HE DOES PRESS THE BULB, HE DOES NOT TRANSFER ANY FLUID TO THE CYLINDERS. THE PATIENT SPECIALIST DISCUSSED WITH THE PATIENT PROPER INFLATION TECHNIQUES AND POSITION AND ATTEMPTING IN A WARM SHOWER. THE PATIENT SPECIALIST SUGGESTED HIM TO BE SEEN BY HIS DOCTOR AGAIN FOR FURTHER EVALUATION AND TO DISCUSS NEXT STEPS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HE HAS BEEN RECENTLY IMPLANTED AND TRAINED BUT IS UNABLE TO INFLATE OR DEFLATE THE DEVICE DUE TO THE HIGH POSITIONING OF THE PUMP. HE STATED THAT IT IS ALSO VERY UNCOMFORTABLE AS IT PRESSES AGAIN THE BASE OF HIS SHAFT AND IS VISIBLE THROUGH CLOTHING. HE STATED HE DID DISCUSS THIS WITH HIS DOCTOR, WHO STATED IT COULD NOT BE MANIPULATED OUTSIDE SURGERY IF AT ALL AND WAS OFFERED TACTRA AS POTENTIAL OPTION. PATIENT STATED THAT WHEN HE DOES PRESS THE BULB, HE DOES NOT TRANSFER ANY FLUID TO THE CYLINDERS. THE PATIENT SPECIALIST DISCUSSED WITH THE PATIENT PROPER INFLATION TECHNIQUES AND POSITION AND ATTEMPTING IN A WARM SHOWER. THE PATIENT SPECIALIST SUGGESTED HIM TO BE SEEN BY HIS DOCTOR AGAIN FOR FURTHER EVALUATION AND TO DISCUSS NEXT STEPS. AFTER CONSULTING WITH THE PHYSICIAN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE PUMP AND REALIGN THE TUBING. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.