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

Model Number	72404234-14
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that his inflatable penile prosthesis (ipp) device was not functioning.Following a consultation with the physician, a magnetic resonance imaging (mri) scan was scheduled.The patient subsequently underwent a device replacement surgery.No patient complications were reported.
Event or Problem Description
It was reported by the patient that his inflatable penile prosthesis (ipp) device was not functioning.Following a consultation with the physician, a magnetic resonance imaging (mri) scan was scheduled.The patient subsequently underwent a device replacement surgery.No patient complications were reported.
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 of mechanical malfunction cannot be confirmed.Additionally, 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.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 23148799
• Report Number: 2124215-2025-66183
• Device Sequence Number: 9938114
• Product Code: JCW
• UDI-Device Identifier: 00878953009803
• UDI-Public: (01)00878953009803(17)220212(10)1000395748
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 02/12/2022
• Device Model Number: 72404234-14
• Device Catalogue Number: 72404234-14
• Device Lot Number: 1000395748
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 02/13/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male