MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404283
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	12/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) experienced prolonged deflation issues, causing pain and discomfort.The physician conducted a physical examination and attempted standard deflation steps, confirming that the prosthesis did not fully deflate; only about 30% deflation was achieved.This partial deflation provided temporary pain relief.A revision surgery will be required but has not yet been scheduled or performed.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) experienced prolonged deflation issues, causing pain and discomfort.The physician conducted a physical examination and attempted standard deflation steps, confirming that the prosthesis did not fully deflate; only about 30% deflation was achieved.This partial deflation provided temporary pain relief.A revision surgery will be required but has not yet been scheduled or performed.No additional patient complications were reported.

• Brand Name: AMS 700 CX MS 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: 24056098
• Report Number: 2124215-2026-01954
• Device Sequence Number: 15789828
• Product Code: JCW
• UDI-Device Identifier: 00878953003863
• UDI-Public: (01)00878953003863(17)260103(10)1000504622
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 01/03/2026
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 1000504622
• 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: 12/20/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/24/2026
• Date Device Manufactured: 01/04/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720182-01 / LOT: 1100197604; RESERVOIR: UPN: 720182-01 / LOT: 1100197604
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male