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

Model Number	72404264
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404264.Serial number: n/a.Batch/lot number: 1100826628.Model/catalog description: cxr preconnect ms 18cm ps iz.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient implanted with an inflatable penile prosthesis (ipp) experienced scrotal pain when operating the momentary squeeze (ms) pump.A surgical procedure was performed, during which no device issue was identified.Although the pump continued to inflate the ipp as intended, its use caused significant pain to the patient.The physician noted difficulty when manipulating the ms pump and elected to replace it with a tenacio pump.The new pump was implanted in a different scrotal pocket.In addition, a capsule believed to be contributing to the patient's pain was excised.No additional patient complications were reported.

• Brand Name: AMS 700 CXR 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: 50087091
• Report Number: 2124215-2026-40976
• Device Sequence Number: 10006096
• Product Code: JCW
• UDI-Device Identifier: 00878953003726
• UDI-Public: (01)00878953003726(17)271106(10)1100826628
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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 Model Number: 72404264
• Device Catalogue Number: 72404264
• Device Lot Number: 1100826628
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/26/2026
• Date Device Manufactured: 11/06/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male