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

Model Number	72404457
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) herniated.The pump and balloon were explanted and replaced.The pump was replaced with the momentary squeeze (ms) pump per patient preference.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.The pump did not pass the inflation functional tests.No leaks were identified.The pump passed the microscope test.The reported pump migration was defined in the product risk documentation.The reservoir was microscopically inspected and leak tested.No anomalies were found with the reservoir.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) herniated.The pump and balloon were explanted and replaced.The pump was replaced with the momentary squeeze (ms) pump per patient preference.No patient complications reported.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) herniated.The pump and balloon were explanted and replaced.The pump was replaced with the momentary squeeze (ms) pump per patient preference.No patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.No anomalies were found with the pump.The reservoir was microscopically inspected and leak tested.No anomalies were found with the reservoir.The reported reservoir migration is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Correction to field h11: additional mfr narrative.

• Brand Name: AMS 700 LGX? TENACIO? 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: 21170002
• Report Number: 2124215-2024-84142
• Device Sequence Number: 9412777
• Product Code: JCW
• UDI-Device Identifier: 00191506021474
• UDI-Public: (01)00191506021474(17)260330(10)1100481244
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: 2024
• 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): 07/07/2025

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: 03/30/2026
• Device Model Number: 72404457
• Device Catalogue Number: 72404457
• Device Lot Number: 1100481244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 03/10/2025; 06/16/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/02/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2024
• 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: LGX 72404457/1100481244; RESERVOIR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male