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
Manufacturer
Boston Scientific CorporationModel number
72404453Catalog 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.