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

Model Number	72404310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this inflatable penile prosthesis (ipp) experienced a scrotal and penile infection.A surgical procedure was performed during which the device was fully explanted and replaced.The infection was treated with disinfection, debridement, and drainage.No device related issues were identified.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 720182-01 serial number: n/a batch/lot number: 1100898351 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4) model number/catalog number: 72404012 serial number: n/a batch/lot number: 1100823403 model/catalog description: cxr 14cm 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: 50488107
• Report Number: 2124215-2026-46065
• Device Sequence Number: 13285181
• Product Code: JCW
• UDI-Device Identifier: 00878953003986
• UDI-Public: (01)00878953003986(17)300428(10)1100718542
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 1100718542
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male