AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE EVENT DATE 05/13/2025 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING WITHIN 2 WEEKS AGO.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS IPP EXPERIENCED SIGNIFICANT POST OPERATIVE DISSATISFACTION, REFERRING TO IT AS THE MOST NEGATIVE SURGICAL EXPERIENCE TO DATE. THE PATIENT REPORTED BEING UNABLE TO FULLY INFLATE THE CYLINDERS, EXPERIENCING ONGOING SORENESS AND DISCOMFORT AT THE INCISION SITE, AND ACHIEVING ONLY PARTIAL INFLATION. THE PUMP WAS DESCRIBED AS EXTREMELY STIFF, RAISING CONCERNS ABOUT A POSSIBLE STICKY VALVE. ADDITIONALLY, THE PHYSICIAN NOTED DURING A PRIOR VISIT THAT THE PUMP APPEARED TO BE POSITIONED HIGHER AND TO THE LEFT WITHIN THE SCROTUM. THE PATIENT MENTIONED THAT ATTEMPTS TO INFLATE THE DEVICE IN WARM WATER PROVIDED SOME RELIEF. A FOLLOW UP APPOINTMENT IS SCHEDULED FOR FURTHER PHYSICIAN EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE EVENT DATE 05/13/2025 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING WITHIN 2 WEEKS AGO. CORRECTION TO FIELD H7: IF REMEDIAL ACT INIT, TYPE CORRECTION TO FIELD H9: CORRECTION/REMOVAL REPORTING NUMBER. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT THEREFORE CONCLUDING MANUFACTURING WAS NOT RELATED TO THE REPORTED EVENT. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SIGNIFICANT POST OPERATIVE DISSATISFACTION, REFERRING TO IT AS THE MOST NEGATIVE SURGICAL EXPERIENCE TO DATE. THE PATIENT REPORTED BEING UNABLE TO FULLY INFLATE THE CYLINDERS, EXPERIENCING ONGOING PAIN AND DISCOMFORT AT THE INCISION SITE, AND ACHIEVING ONLY PARTIAL INFLATION. THE PUMP WAS DESCRIBED AS EXTREMELY STIFF AND NOTED DURING A PRIOR VISIT THAT THE PUMP APPEARED TO BE POSITIONED HIGH AND TO THE LEFT WITHIN THE SCROTUM. THE PATIENT MENTIONED THAT ATTEMPTS TO INFLATE THE DEVICE IN WARM WATER PROVIDED SOME RELIEF. ADDITIONAL INFORMATION STATED THAT DURING PHYSICIAN FOLLOW UP APPOINTMENT TOPICAL LIDOCAINE WAS PROVIDED FOR PAIN, AND A SECOND OPINION WAS RECOMMENDED. NO ADDITIONAL INTERVENTIONS WERE NOTED, AND REVISION SURGERY HAD NOT BEEN CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SIGNIFICANT POST-OPERATIVE DISSATISFACTION, REFERRING TO IT AS THE MOST NEGATIVE SURGICAL EXPERIENCE TO DATE. THE PATIENT REPORTED BEING UNABLE TO FULLY INFLATE THE CYLINDERS, EXPERIENCING ONGOING PAIN AND DISCOMFORT AT THE INCISION SITE, AND ACHIEVING ONLY PARTIAL INFLATION. THE PUMP WAS DESCRIBED AS EXTREMELY STIFF AND NOTED DURING A PRIOR VISIT THAT THE PUMP APPEARED TO BE POSITIONED HIGH AND TO THE LEFT WITHIN THE SCROTUM. THE PATIENT MENTIONED THAT ATTEMPTS TO INFLATE THE DEVICE IN WARM WATER PROVIDED SOME RELIEF. ADDITIONAL INFORMATION STATED THAT DURING PHYSICIAN FOLLOW UP APPOINTMENT TOPICAL LIDOCAINE WAS PROVIDED FOR PAIN, AND A SECOND OPINION WAS RECOMMENDED. NO ADDITIONAL INTERVENTIONS WERE NOTED, AND REVISION SURGERY HAD NOT BEEN CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE EVENT DATE 05/13/2025 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING WITHIN 2 WEEKS AGO. CORRECTION TO FIELD B5: DESCRIBE EVENT OR PROBLEM. CORRECTION TO FIELD H6: DEVICE CODES. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. REVIEW OF THE DHR CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT THEREFORE CONCLUDING MANUFACTURING WAS NOT RELATED TO THE REPORTED EVENT. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS IPP EXPERIENCED SIGNIFICANT POST OPERATIVE DISSATISFACTION, REFERRING TO IT AS THE MOST NEGATIVE SURGICAL EXPERIENCE TO DATE. THE PATIENT REPORTED BEING UNABLE TO FULLY INFLATE THE CYLINDERS, EXPERIENCING ONGOING PAIN AND DISCOMFORT AT THE INCISION SITE, AND ACHIEVING ONLY PARTIAL INFLATION. THE PUMP WAS DESCRIBED AS EXTREMELY STIFF AND NOTED DURING A PRIOR VISIT THAT THE PUMP APPEARED TO BE POSITIONED HIGH AND TO THE LEFT WITHIN THE SCROTUM. THE PATIENT MENTIONED THAT ATTEMPTS TO INFLATE THE DEVICE IN WARM WATER PROVIDED SOME RELIEF. ADDITIONAL INFORMATION STATED THAT DURING PHYSICIAN FOLLOW UP APPOINTMENT TOPICAL LIDOCAINE WAS PROVIDED FOR PAIN, AND A SECOND OPINION WAS RECOMMENDED. NO ADDITIONAL INTERVENTIONS WERE NOTED, AND REVISION SURGERY HAD NOT BEEN CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). THE EVENT DATE 05/13/2025 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING WITHIN 2 WEEKS AGO.