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

Model Number	72404253-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The allegations of fluid leak, foreign material present in device and mechanical issue were not confirmed.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.A clear probable cause for the event cannot be established; therefore, the conclusion code of unable to exclude device problem was selected.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed a fluid leak and the presence of contamination.The physician explanted and replaced the device.No patient complications were reported.

• Brand Name: AMS 700 LGX MS 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: 24204650
• Report Number: 2124215-2026-05165
• Device Sequence Number: 15868586
• Product Code: JCW
• UDI-Device Identifier: 00878953009827
• UDI-Public: (01)00878953009827(17)260513(10)1100511032
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Report Date (Section B): 01/28/2026

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 Expiration Date: 05/13/2026
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1100511032
• 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: 08/05/2025
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 05/13/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male