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

Model Number	72404457
Medical Device Problem Codes	Migration (4003); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/03/2026
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 associated with the pump and reported that the pump had adhered to the side of the scrotum.The patient also reported difficulty with deflation, stating that the deflation button would become stuck and required repeated attempts to activate.The patient indicated that the device was able to inflate as expected but that the deflation function was inconsistent.The patient has been advised to follow up with the physician.There were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100862382.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (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 symptom of incontinence is a known risk 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: 25017767
• Report Number: 2124215-2026-22838
• Device Sequence Number: 21229446
• Product Code: JCW
• UDI-Device Identifier: 00191506021474
• UDI-Public: (01)00191506021474(17)270927(10)1100801064
• 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: 2026
• 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): 04/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404457
• Device Catalogue Number: 72404457
• Device Lot Number: 1100801064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 09/27/2025
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male