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

Model Number	72404258
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of adhesions is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.B3.Date of event: actual event date was unknown; therefore, first day of bsc aware month was selected.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) stated that the bulb was positioned at the top of the scrotum and felt as though the right testicle was attached to it.The patient also reported that the bulb appeared to be affixed to the scrotum.The device remains implanted, and the patient was advised to follow up with his physician.No additional information was provided.

• 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: 23015484
• Report Number: 2124215-2025-63475
• Device Sequence Number: 18526406
• Product Code: JCW
• UDI-Device Identifier: 00878953003665
• UDI-Public: (01)00878953003665(17)270403(10)1100704133
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 1100704133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/10/2025
• Date Device Manufactured: 04/03/2025
• 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: 82 YR
• Patient Sex: Male