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

Model Number	72404431
Medical Device Problem Codes	Inflation Problem (1310); Malposition of Device (2616); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was experiencing discomfort due to pump positioning.The patient stated that the pump sits in a difficult location, making it challenging to inflate and deflate, though he is still able to operate it with maneuvering.No further patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of discomfort is a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was experiencing discomfort due to pump positioning.The patient stated that the pump is painful, difficult to reach, and challenging to inflate and deflate.He also reported that the ipp pump is placing pressure on the artificial urinary sphincter (aus) pump, causing additional discomfort.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms of discomfort and pain are known risks associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was experiencing discomfort due to pump positioning.The patient stated that the pump is painful, difficult to reach, and challenging to inflate and deflate.He also reported that the ipp pump is placing pressure on the artificial urinary sphincter (aus) pump, causing additional discomfort.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms of discomfort and pain are known risks associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.

• Brand Name: AMS 700? CX 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: 22932669
• Report Number: 2124215-2025-59656
• Device Sequence Number: 10231015
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 72404431
• Device Catalogue Number: 72404431
• Device Lot Number: 1100669914
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/20/2026; 01/10/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/04/2025; 01/23/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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: RESERVOIR. LOT: 1100669564 UPN: 72404155; RESERVOIR. LOT: 1100669564 UPN: 72404155; RESERVOIR. LOT: 1100669564 UPN: 72404155
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male