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

Model Number	72404301
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not fully inflating, and the pump would occasionally get stuck.The patient underwent several ultrasound evaluations that showed a mechanical problem with the device.The device is currently implanted, and the explant surgery is already booked.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not fully inflating, and the pump would occasionally get stuck.The patient underwent several ultrasound evaluations that showed a mechanical problem with the device.The device is currently implanted, and the explant surgery is already booked.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (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: 22092110
• Report Number: 2124215-2025-33765
• Device Sequence Number: 17876329
• Product Code: JCW
• UDI-Device Identifier: 00878953005720
• UDI-Public: (01)00878953005720(17)260620(10)1000585602
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 06/20/2026
• Device Model Number: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 1000585602
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720182-01 LOT 1100197545; RESERVOIR UPN 720182-01 LOT 1100197545
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male