MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX; prosthesis, penis, inflatable

Model Number	72404291
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	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which a crack was found in the pump connecting tube, so the pump was replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product implanted at time of the event: (b)(6) 2026.Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 900158019.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 904356001.Model/catalog description: pump ms.Unique identifier (udi) #: (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: 50460815
• Report Number: 2124215-2026-45746
• Device Sequence Number: 9972606
• Product Code: JCW
• UDI-Device Identifier: 00878953003931
• UDI-Public: (01)00878953003931(17)190617(10)889207001
• 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: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/17/2019
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 889207001
• 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: 07/27/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 07/04/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown