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

Model Number	72404451
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
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 maintain an erection because the pump would not inflate the device.A surgical procedure was performed, during which a break in the tubing was identified, causing fluid loss.As a result, the device was removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100577575.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).

• 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: 50576881
• Report Number: 2124215-2026-46890
• Device Sequence Number: 15920742
• Product Code: JCW
• UDI-Device Identifier: 00191506021429
• UDI-Public: (01)00191506021429(17)260820(10)1100574782
• 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: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 08/20/2026
• Device Model Number: 72404451
• Device Catalogue Number: 72404451
• Device Lot Number: 1100574782
• 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: 08/07/2026
• Initial Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 08/20/2024
• 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: 61 YR
• Patient Sex: Male