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

Model Number	72404458
Medical Device Problem Codes	Inflation Problem (1310); Patient-Device Incompatibility (2682); Migration (4003); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
A patient with an inflatable penile prosthesis device reported discomfort and pain in the scrotum and had difficulties during the cycling activation appointment, being unable to easily inflate or deflate the device.Attempts to manipulate the pump were unsuccessful, and the patient was advised to practice at home.The physician observed that the pump retracted and migrated high and deep in the scrotum, making the deflation button hard to find and lacking tactile feedback, complicating training.No medical or surgical interventions have been made yet, but the physician believes a pump repositioning may be necessary and suspects the pump caused the pain and discomfort.It was also confirmed by the physician that there was no external pressure or trauma to the pelvic region or abdomen prior to the appointment.There were no further patient complications.
Additional Manufacturer Narrative
Udi field (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 number.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation of difficulty to deflate/ inflate and migration cannot be confirmed.Discomfort, pain and patient-device incompatibility are acknowledged within the dfu and is not related to off-label use or failure to follow instructions.The reported patient symptoms of discomfort and pain are a known risk associated with this device type and indicated as such in the instructions for use.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
A patient with an inflatable penile prosthesis (ipp) device reported discomfort and pain in the scrotum and had difficulties during the cycling activation appointment, being unable to easily inflate or deflate the device.Attempts to manipulate the pump were unsuccessful, and the patient was advised to practice at home.The physician observed that the pump retracted and migrated high and deep in the scrotum, making the deflation button hard to find and lacking tactile feedback, complicating training.No medical or surgical interventions have been made yet, but the physician believes a pump repositioning may be necessary and suspects the pump caused the pain and discomfort.It was also confirmed by the physician that there was no external pressure or trauma to the pelvic region or abdomen prior to the appointment.There were no further patient complications.

• 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: 21893163
• Report Number: 2124215-2025-25493
• Device Sequence Number: 15492450
• Product Code: JCW
• UDI-Device Identifier: 00191506021481
• UDI-Public: (01)00191506021481(17)260725(10)1100556136
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Expiration Date: 07/25/2026
• Device Model Number: 72404458
• Device Catalogue Number: 72404458
• Device Lot Number: 1100556136
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 07/25/2024
• 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 LOT 1100614670, UPN 72404156; RESERVOIR LOT 1100614670, UPN 72404156
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White