MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700? CXR TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404466
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experience achy pain in the scrotum.The event of pain has been resolved three weeks later.Additionally, the patient was dissatisfied with device due to perceived loss of penile length during an erection; however, is not related to the device and procedure.A surgical procedure was performed for the revision of one of the components of the ipp.Additionally, an infrapubic pannus resection was performed.No additional information.
Additional Manufacturer Narrative
Model number/catalog number: 72404155, serial number: n/a, batch/lot number: unknown, model/catalog description: reservoir 65 ml pc/iz, unique identifier (udi) #: (b)(4).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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 symptom of pain is known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 50223115
• Report Number: 2124215-2026-43187
• Device Sequence Number: 5545150
• Product Code: JCW
• UDI-Device Identifier: 00191506021559
• UDI-Public: (01)00191506021559
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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 Model Number: 72404466
• Device Catalogue Number: 72404466
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 224 LB