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

Model Number	72404452
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.D4.Concomitant product udi for reservoir is (b)(4).Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.
Additional Manufacturer Narrative
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 patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) underwent a revision procedure to activate the device.The physician was unable to achieve full inflation, as the implant did not inflate or deflate.The patient reported that when attempting to inflate the device, the pump felt rigid, his scrotum was very sore, and he could not continue trying.The device remains implanted, and a replacement surgery is planned.The patient was advised to contact his physician.No additional information has been reported.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) underwent a revision procedure to activate the device.The physician was unable to achieve full inflation, as the implant did not inflate or deflate.The patient reported that when attempting to inflate the device, the pump felt rigid, his scrotum was very sore, and he could not continue trying.The device remains implanted, and a replacement surgery is planned.The patient was advised to contact his physician.No additional information has been 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: 23820998
• Report Number: 2124215-2025-91200
• Device Sequence Number: 10104767
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)261028(10)1100620589
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100620589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 10/28/2024
• 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-0144-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720185-01 LOT 1100702014.; RESERVOIR UPN 720185-01 LOT 1100702014.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male