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

Model Number	72404310
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Erosion (1750); Fluid Discharge (2686)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an inflatable penile prosthesis (ipp) stopped functioning.The patient experienced tissue fluid drainage from the surgical wound and the pump area.The pump became exposed, and the cylinder extruded.Subsequently, the patient was hospitalized for treatment.Some time later, all device components were removed.Once the patient has recovered, a new ipp will be implanted.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404013 serial number: n/a batch/lot number: 1100625073 model/catalog description: cxr 16cm unique identifier (udi) #: (b)(4).Model number/catalog number: 72018201 serial number: n/a batch/lot number: 1100700399 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).

• Brand Name: AMS 700 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: 50127948
• Report Number: 2124215-2026-41635
• Device Sequence Number: 20252581
• Product Code: JCW
• UDI-Device Identifier: 00878953003986
• UDI-Public: (01)00878953003986(17)300211(10)1100675620
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1100675620
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 08/09/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/12/2025
• 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: 67 YR
• Patient Sex: Male