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

Model Number	72404234-14
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Human-Device Interface Problem (2949); Failure to Deflate (4060)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1000033372.Model/catalog description: reservoir 100 ml pc/iz.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.The patient also reported having undergone multiple replacement procedures since 1995, including a revision on (b)(6) 1998 and subsequent surgeries on (b)(6) 2014 and (b)(4) 2018.The patient stated that during a previous revision procedure on the physician was unable to locate the reservoir from an earlier implant and elected to leave it in place.Following the procedure, the patient experienced significant pain and expressed dissatisfaction with the post-operative care provided.The patient further reported that the pump felt extremely hard after surgery and was very difficult to manipulate in order to deflate or soften.Subsequently, the device was evaluated by another physician, who agreed that the ipp was no longer functioning properly, as it would neither pump nor inflate.However, this physician no longer performs ipp surgeries.The patient was provided with information for specialists in the area to obtain a second opinion.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: 50142810
• Report Number: 2124215-2026-41907
• Device Sequence Number: 9142718
• Product Code: JCW
• UDI-Device Identifier: 00878953009803
• UDI-Public: (01)00878953009803(17)200606(10)1000118137
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/06/2020
• Device Model Number: 72404234-14
• Device Catalogue Number: 72404234-14
• Device Lot Number: 1000118137
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 06/07/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male