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

Model Number	72404283-12
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: actual event date was unknown; therefore, first day of bsc aware month was selected.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experience discomfort and subacute infection.The device was hard to pump.The patient underwent clinical treatment with extended intravenous antibiotic therapy and was admitted to hospital.The device is still implanted.A revision surgery will be performed on (b)(6) 2025.No further patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experience discomfort and subacute infection.The device was hard to pump.The patient underwent clinical treatment with extended intravenous antibiotic therapy and was admitted to hospital.The device is still implanted.A revision surgery will be performed on (b)(6) 2025.No further patient complications reported.
Additional Manufacturer Narrative
B3.Date of event: actual event date was unknown; therefore, first day of bsc aware month was selected.B1 adverse event/product problem was inadvertently left blank in the previous submission.
Additional Manufacturer Narrative
B3.Date of event: actual event date was unknown; therefore, first day of bsc aware month was selected.B1 adverse event/product problem was inadvertently left blank in the previous submission.D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experience discomfort and subacute infection.The device was hard to pump.The patient underwent clinical treatment with extended intravenous antibiotic therapy and was admitted to hospital.The ipp was explanted and replaced.No further patient complications 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: 21707006
• Report Number: 2124215-2025-18502
• Device Sequence Number: 15970481
• Product Code: JCW
• UDI-Device Identifier: 00878953009841
• UDI-Public: (01)00878953009841(17)271219(10)1100234709
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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 Model Number: 72404283-12
• Device Catalogue Number: 72404283-12
• Device Lot Number: 1100234709
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 05/12/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 03/31/2025; 05/30/2025
• Date Device Manufactured: 12/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN. 720185-01 LOT. 1100504301.; RESERVOIR UPN. 720185-01 LOT. 1100504301.; RESERVOIR UPN. 720185-01 LOT. 1100504301.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male