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

Model Number	72404161
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404233.Serial number: n/a.Batch/lot number: 1100469872.Model/catalog description: cx preconnect ms 21cm ps 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.Pain is acknowledged within the ifu and are not related to off label use or failure to follow instructions.Discomfort is acknowledged within the ifu and are not related to off label use or failure to follow instructions.Device migration is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent migration issues.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) implant device experienced pain and a sensation of a mass/lump in the inguinal region.The pain was uncomfortable but was not severe or acute such that it required treatment.Upon examination, the physician reported that the reservoir had shifted/moved.The reservoir was previously located in the space of retzius, and had migrated to the inguinal region.A surgical procedure was performed during which the reservoir was repositioned, and there were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404233 serial number: n/a batch/lot number: 1100469872 model/catalog description: cx preconnect ms 21cm ps 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.Migration, discomfort, 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 symptoms are known risks associated with this device type and is indicated as such in the instructions for use.A risk review confirmed that the events of pain, discomfort, and migration 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 known inherent risk was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) implant device experienced pain and a sensation of a mass/lump in the inguinal region.The pain was uncomfortable but was not severe or acute such that it required treatment.Upon examination, the physician reported that the reservoir had shifted/moved.The reservoir was previously located in the space of retzius, and had migrated to the inguinal region.A surgical procedure was performed during which the reservoir was repositioned, and there were no further patient complications reported.

• Brand Name: AMS 700 SPHERICAL RESERVOIR
• 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 ; 5086521217
• MDR Report Key: 24594633
• Report Number: 2124215-2026-14042
• Device Sequence Number: 9434753
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)290210(10)1100446667
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/14/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 1100446667
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male