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

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the right cylinder connecting tube.The pump was explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the right cylinder connecting tube.The pump was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).

• Brand Name: AMS 700 LGX
• 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: 22751823
• Report Number: 2124215-2025-54269
• Device Sequence Number: 18305590
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)190904(10)898829001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/18/2025

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: 09/04/2019
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 898829001
• 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: 07/13/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 09/24/2014
• 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: UPN: 4161 LOT: 886892007- RESERVOIR.; UPN: 4161 LOT: 886892007- RESERVOIR.; UPN: 4310 LOT: 908923002- PUMP.; UPN: 4310 LOT: 908923002- PUMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male