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

Model Number	72404302
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated this inflatable penile prosthesis (ipp) was not working properly, as pump is staying collapsed preventing cylinder inflation.The physician evaluated the device and confirmed the issue; therefore, a replacement surgery was scheduled.No additional information was reported.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 11/01/2024 was used as estimate, as it was reported that device issues started in november 2024.
Event or Problem Description
It was reported that the patient stated this inflatable penile prosthesis (ipp) was not working properly, as pump was staying collapsed preventing cylinder inflation.The physician evaluated the device and confirmed the issue; therefore, a revision surgery was performed, in which it was noted that the tubing between reservoir and pump was disconnected.The system was purged, cleaned, refilled and reconnected.No components were replaced, and no patient complications were reported.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 11/01/2024 was used as estimate, as it was reported that device issues started in (b)(6) 2024.Additional information updated: b5: describe event/problem.B1: adverse event/product problem.B2: outcomes attrib to adv event.D6b: explant date.H6: impact and device codes.

• Brand Name: AMS 700 LGX 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: 21255237
• Report Number: 2124215-2025-03962
• Device Sequence Number: 8056221
• Product Code: JCW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 03/19/2025

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: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100160703
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/19/2025
• Date Device Manufactured: 07/30/2022
• 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: 720182-01/ LOT: 1100197548.; RESERVOIR: UPN: 720182-01/ LOT: 1100197548.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male