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

Model Number	72404452
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was dissatisfied with the placement of the cylinders, as the previous implant had not been fully dilated.A surgical procedure was performed in which the device was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issue with malposition may have been due to a potential error in the location of the placement.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was dissatisfied with the placement of the cylinders, as the previous implant had not been fully dilated.A surgical procedure was performed in which the device was removed and replaced.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: 23143486
• Report Number: 2124215-2025-66300
• Device Sequence Number: 21043391
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)260329(10)1100480677
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: 2025
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/29/2026
• Device Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100480677
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 03/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UPN: 720185-01 LOT: 1100583501. RESERVOIR.; UPN: 720185-01 LOT: 1100583501. RESERVOIR.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown