MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX? TENACIO? PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404458
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) would not stay inflated during use.The issue was reported during a routine follow-up appointment.The physician cycled the device in-office and discussed the pressure release mechanism.Replacement of the pump is being considered.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) would not stay inflated during use.The issue was reported during a routine follow-up appointment.The physician cycled the device in-office and discussed the pressure release mechanism.Replacement of the pump is being considered.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.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.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.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) would not stay inflated during use.The issue was reported during a routine follow-up appointment.The physician cycled the device in-office and discussed the pressure release mechanism.Replacement of the pump is being considered.There were no patient complications reported.

• 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: 22749212
• Report Number: 2124215-2025-53689
• Device Sequence Number: 15605027
• Product Code: JCW
• UDI-Device Identifier: 00191506021481
• UDI-Public: (01)00191506021481(17)260710(10)1100545961
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/10/2026
• Device Model Number: 72404458
• Device Catalogue Number: 72404458
• Device Lot Number: 1100545961
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 01/20/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/18/2025; 02/11/2026
• Date Device Manufactured: 07/10/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0143-2026
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male