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

Model Number	72404461
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 approximated.D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) is unable to activate the device to inflate it, also the patient is having difficulty activating the device due to severe pain.The patient is concerned about the situation and has an appointment with the physician to discuss next steps.There is no additional information reported.

• Brand Name: AMS 700? CXR 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: 21973284
• Report Number: 2124215-2025-27785
• Device Sequence Number: 7265000
• Product Code: JCW
• UDI-Device Identifier: 00191506021504
• UDI-Public: (01)00191506021504(17)261011(10)1100610217
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 72404461
• Device Catalogue Number: 72404461
• Device Lot Number: 1100610217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 10/11/2024
• 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 1100617552
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male