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

Model Number	72404451
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced scrotal pain, swelling, redness, and pump migration.A revision surgery was performed, during which the physician confirmed an infection in the scrotum started one week prior the procedure.The entire device was explanted and discarded, the area was fully cleaned and irrigated heavily, and only new cylinders were implanted as a placeholder.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced scrotal pain, swelling, redness, and pump migration.A revision surgery was performed, during which the physician confirmed an infection in the scrotum started one week prior the procedure.The entire device was explanted and discarded, the area was fully cleaned and irrigated heavily, and only new cylinders were implanted as a placeholder.No further patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The reported allegations of infection, pain, swelling, redness, and migration are known risks 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: 23584092
• Report Number: 2124215-2025-81575
• Device Sequence Number: 9398313
• Product Code: JCW
• UDI-Device Identifier: 00191506021429
• UDI-Public: (01)00191506021429(17)270506(10)1100723760
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Model Number: 72404451
• Device Catalogue Number: 72404451
• Device Lot Number: 1100723760
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 05/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male