MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX MS Pump; prosthesis, penis, inflatable

Model Number	72404256
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not achieving full rigidity.A potential kink in the pump tubing was suspected; however, the presence of a kink could not be confirmed, as no specific issue was identified with any individual component of the device.The suspected cause of the malfunction was either long term device use or changes associated with the healing process that may have resulted in a tubing kink.As a result, a surgical revision procedure was performed to replace the pump.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100786294 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #:(b)(4).

• 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: 50168036
• Report Number: 2124215-2026-42308
• Device Sequence Number: 14778873
• Product Code: JCW
• UDI-Device Identifier: 00878953003641
• UDI-Public: (01)00878953003641(17)270626(10)1100751179
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 72404256
• Device Catalogue Number: 72404256
• Device Lot Number: 1100751179
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 06/26/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male