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

Model Number	72404252
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain upon activation of the device.During revision surgery, the physician confirmed the presence of infection.The device was explanted and replaced with a malleable penile prosthesis.There were no further patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 843566001.Model/catalog description: reservoir parylene coated with iz.Unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Infection and pain are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.The reported patient symptom of infection and pain are known risks associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain upon activation of the device.During revision surgery, the physician confirmed the presence of infection.The device was explanted and replaced with a malleable penile prosthesis.There were no further patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72404156 serial number: n/a batch/lot number: 843566001 model/catalog description: reservoir parylene coated with iz unique identifier (udi) #:(b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Pain and infection are acknowledged within the ifu and are not related to off label use or failure to follow instructions.The reported patient symptoms are known risks associated with this device type and are indicated as such in the instructions for use.A risk review confirmed that the events of infection and pain were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of adverse event related to patient condition was assigned to this investigation as the patients existing condition, disease, or anatomy is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced the adverse event.

• 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 ; +1(508)652-1217
• MDR Report Key: 25742690
• Report Number: 2124215-2026-36499
• Device Sequence Number: 21393026
• Product Code: JCW
• UDI-Device Identifier: 00878953003603
• UDI-Public: (01)00878953003603(17)150513(10)828276002
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/05/2026

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: 05/13/2015
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 828276002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 05/28/2013
• 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: 80 YR
• Patient Sex: Male