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

Model Number	72404431
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Discomfort (2330)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) complained of pain and difficulty using the implant.During surgery, erosion at the pump site was confirmed, along with an increased risk of infection.A surgical procedure was performed in which the entire device was removed, and no replacement device was implanted.There were no further 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.There was no report of a device performance allegation.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) complained of pain, discomfort and difficulty using the implant.Upon clinical examination, erosion at the pump site was identified, with an infection localized in the scrotum.The physician believed that the device contributed to the erosion, as the pump was visualized beginning to erode through the skin.A surgical procedure was performed in which the entire device was removed, and no replacement device was implanted.The infection was treated with antibiotics.There were no further 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.There was no report of a device performance allegation.The reported patient symptoms are known risks associated with this device type and indicated as such in the instructions for use.

• Brand Name: AMS 700? CX 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: 23832217
• Report Number: 2124215-2025-91565
• Device Sequence Number: 5093495
• Product Code: JCW
• UDI-Device Identifier: 00191506021320
• UDI-Public: (01)00191506021320(17)260625(10)1100537421
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/25/2026
• Device Model Number: 72404431
• Device Catalogue Number: 72404431
• Device Lot Number: 1100537421
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 06/25/2024
• 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: LOT: 1100727625 UPN: 720185-01. RESERVOIR; LOT: 1100727625 UPN: 720185-01. RESERVOIR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Unknown