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

Model Number	72404302
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with an inability to inflate their inflatable penile prosthesis ipp device after three years of use.The patient alleges that when trying to activate it, the device will not fill when pressing the filling pump, it is very hard and does not send the liquid.The physician suspected during a revision appointment that the patient was having difficulty manipulating the pump due to a mechanical issue related to the pump, leading to the inability to inflate the device.Patient next appointment for revision would be scheduled in the operating room for explantation of the device and implantation of a new one.The patient currently has the device implanted, and it has not been changed or removed.The next course of action is to remove the device and implant a new one.There were no patient complications.
Additional Manufacturer Narrative
Correction to field c2 d10: concomitant product therapy.
Event or Problem Description
It was reported that the patient presented with an inability to inflate their inflatable penile prosthesis (ipp) device after three years of use.The patient alleges that when trying to activate it, the device will not fill when pressing the filling pump; it is very hard and does not send the liquid.The physician suspected during a revision appointment that the patient was having difficulty manipulating the pump due to a mechanical issue related to the pump, leading to the inability to inflate the device.Patient next appointment for revision would be scheduled in the operating room for explantation of the device and implantation of a new one.The patient currently has the device implanted, and it hasn't been changed or removed.The next course of action is to remove the device and implant a new one.There were no patient complications.
Event or Problem Description
It was reported that the patient presented with an inability to inflate their inflatable penile prosthesis ipp device after three years of use.The patient alleged that when trying to activate it, the device would not fill when pressing the filling pump; it was very hard and did not send the liquid.During a revision appointment, the physician suspected that the patient was having difficulty manipulating the pump due to a mechanical issue, leading to the inability to inflate the device.A revision surgery was performed in which the physician confirmed that the device would not fill when pressing the filling pump.No additional information was provided.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient presented with an inability to inflate their inflatable penile prosthesis device after three years of use.The patient alleged that when trying to activate it, the device would not fill when pressing the filling pump; it was very hard and did not send the liquid.During a revision appointment, the physician suspected that the patient was having difficulty manipulating the pump due to a mechanical issue, leading to the inability to inflate the device.A revision surgery was performed in which the physician confirmed that the pump would not fill when pressing the filling pump.The device was explanted and replaced.There were no patient complications.

• 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: 21547430
• Report Number: 2124215-2025-14023
• Device Sequence Number: 7642943
• Product Code: JCW
• UDI-Device Identifier: 00878953005737
• UDI-Public: (01)00878953005737(17)251214(10)1000502335
• 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: 2021
• 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,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 12/14/2025
• Device Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1000502335
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 04/15/2025; 05/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/10/2025; 05/13/2025; 06/10/2025
• Date Device Manufactured: 12/15/2020
• 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 LOT 1000510442, UPN 72018201; RESERVOIR LOT 1000510442, UPN 72018201; RESERVOIR LOT 1000510442, UPN 72018201
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male