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

Model Number	72404457
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) migrated out of corpora due to bad tissue and lack of capsule formation.The ipp was explanted and replaced.There is no additional information reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for lgx 18: (b)(4).
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).Updated describe event or problem b5, lot number, catalog number and unique identifier (udi) # d4, and concomitant product/therapy c2/d10.
Event or Problem Description
It was reported that the right cylinder of this inflatable penile prosthesis (ipp) migrated out of corpora due to bad tissue and lack of capsule formation.The ipp was explanted and replaced.There is no additional information reported.

• Brand Name: AMS 700 LGX? TENACIO? 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: 22745377
• Report Number: 2124215-2025-54174
• Device Sequence Number: 8386007
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207(17)260917(10)1100592355
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 09/23/2026
• Device Model Number: 72404457
• Device Catalogue Number: 72404457
• Device Lot Number: 1100595938
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/29/2025
• Date Device Manufactured: 09/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LGX 18: UPN 72404457 / LOT 1100595938; RESERVOIR: UPN 72404155 / LOT 1100592355
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male