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

Model Number	72404468
Medical Device Problem Codes	Mechanical Problem (1384); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain and discomfort on the scrotum.It was noticed that the pump was difficult to cycle.The pump retracted back very high and deep in the scrotum; the deflation button was harder to find.The device is still implanted.No further patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) discomfort on the scrotum.It was noticed that the pump was difficult to cycle.The pump retracted back very high and deep in the scrotum; the deflation button was harder to find.The device is still implanted.No further patient complications 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: 21892017
• Report Number: 2124215-2025-25603
• Device Sequence Number: 8161979
• Product Code: JCW
• UDI-Device Identifier: 00191506021573
• UDI-Public: (01)00191506021573(17)261105(10)1100624980
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 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: 72404468
• Device Catalogue Number: 72404468
• Device Lot Number: 1100624980
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 11/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male