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

Model Number	72404258
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device performance allegations cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) indicated that the cylinders were not inflating completely, resulting in insufficient rigidity.During the explant procedure, a hole was discovered in the left cylinder.It is also believed the patient may be using penile injections in an attempt to achieve greater rigidity.There were no patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) indicated that the cylinders were not inflating completely, resulting in insufficient rigidity.During the explant procedure, a hole was discovered in the left cylinder.It is also believed the patient may be using penile injections in an attempt to achieve greater rigidity.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) indicated that the cylinders were not inflating completely, resulting in insufficient rigidity.During the explant procedure, a hole was discovered in the left cylinder.It is also believed the patient may be using penile injections in an attempt to achieve greater rigidity.There were no patient complications reported.

• 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: 22501956
• Report Number: 2124215-2025-46396
• Device Sequence Number: 15207065
• Product Code: JCW
• UDI-Device Identifier: 00878953003665
• UDI-Public: (01)00878953003665(17)251029(10)1100386278
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/29/2025
• Device Model Number: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 1100386278
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 01/07/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/03/2025; 02/06/2026
• Date Device Manufactured: 10/30/2023
• 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: 72404156 / LOT: 1100387949; RESERVOIR: UPN: 72404156 / LOT: 1100387949; RESERVOIR: UPN: 72404156 / LOT: 1100387949
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male