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

Model Number	72404452
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100749499.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.The device was noted to be improperly positioned and oversized.As a result, the cylinders and pump were explanted and replaced with a smaller size, while the reservoir was retained.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.The device was noted to be improperly positioned and oversized.As a result, the cylinders and pump were explanted and replaced with a smaller size, while the reservoir was retained.No further patient complications were reported.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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 events of pain or discomfort, incorrect cylinder size and device malposition 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 reported issues with the inflatable penile prosthesis (ipp) may have been due to an improperly positioned and oversized implant.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

• Brand Name: AMS 700 LGX¿ TENACIO¿ 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: 25876863
• Report Number: 2124215-2026-38771
• Device Sequence Number: 8047192
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)260605(10)1100526095
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/27/2026

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: 06/05/2026
• Device Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100526095
• 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: 06/22/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 06/05/2024
• 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: 78 YR
• Patient Sex: Unknown