MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX TENACIO PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404453
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.
Event or Problem Description
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 within the scrotum.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.The physician stated that the migration may be due to the new location of the reservoir tubing connecting to the tenacio pump.There were no additional patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.

• Brand Name: AMS 700 LGX TENACIO PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20904118
• Report Number: 2124215-2024-78313
• Device Sequence Number: 18436787
• Product Code: JCW
• UDI-Device Identifier: 00191506021443
• UDI-Public: 00191506021443
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: 72404453
• Device Catalogue Number: 72404453
• Device Lot Number: 1100523972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/31/2025; 11/07/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/20/2025; 12/03/2025
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720185-01 LOT: 1100557434; RESERVOIR: UPN: 720185-01 LOT: 1100557434
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Unknown