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

Model Number	72404303
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with malfunction of the prosthesis.It was noted that the prosthesis migrated from the corpus cavernosum to being partially located subcutaneously.The ipp is currently implanted.There were no patient complications.
Additional Manufacturer Narrative
Updated adverse event/product problem b1, outcomes attrib to adv event b2, describe event or problem b5, explant date d6b, type of reportable event h1 and, h6 impact codes and evaluation conclusion codes.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with malfunction of the prosthesis.It was noted that the prosthesis migrated from the corpus cavernosum to being partially located subcutaneously.The ipp was explanted and replaced with a tactra.There were no patient complications.

• 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: 20184279
• Report Number: 2124215-2024-56404
• Device Sequence Number: 18217161
• Product Code: JCW
• UDI-Device Identifier: 00878953005744
• UDI-Public: (01)00878953005744(17)260602(10)1000565481
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 06/20/2025

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: 06/02/2026
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 1000565481
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 06/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RTE: UPN 72404322 / LOT 1100245420.; RTE: UPN 72404322 / LOT 1100245420.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male