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

Model Number	72404251
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) was unable to inflate or deflate the device.The patient complained that the device was too difficult to pump and did not become rigid enough.However, the physician stated that there was no device deficiency and that the issue was related to the patients willingness to use the device.A surgical procedure was performed to remove the existing ipp and replace with a new ipp with a tenacio pump.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) was unable to inflate or deflate the device.The patient complained that the device was too difficult to pump and did not become rigid enough.However, the physician stated that there was no device deficiency and that the issue was related to the patient's willingness to use the device.A surgical procedure was performed to remove the existing ipp and replace with a new ipp with a tenacio pump.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100174572.Model/catalog description: reservoir 65 ml pc/iz.Unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Model number/catalog number: 72404155, batch/lot number: 1100174572, model/catalog description: reservoir 65 ml pc/iz, unique identifier (udi) #: (b)(4), the device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of patient dissatisfaction (with length, ability to use and nonspecific reasons) was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, no problem was detected that contributed to the reported event.Therefore, a conclusion code of no problem detected was assigned to this investigation.

• 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: 50225889
• Report Number: 2124215-2026-43264
• Device Sequence Number: 18716326
• Product Code: JCW
• UDI-Device Identifier: 00878953003597
• UDI-Public: (01)00878953003597(17)240606(10)1100140778
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 06/06/2024
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1100140778
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/07/2022
• 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 Age: 58 YR
• Patient Sex: Male