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

Model Number	72404456
Medical Device Problem Codes	Deflation Problem (1149); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced deflation during intercourse with tenacio pump.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, leak and functionally tested.The pump passed visual inspection.No damage or abnormalities were found.The pump passed both leakage and functional test.Based on the information available and analysis results, the reported device allegation is unable to be confirmed.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced deflation during intercourse with tenacio pump.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.

• 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: 22035869
• Report Number: 2124215-2025-31573
• Device Sequence Number: 9484168
• Product Code: JCW
• UDI-Device Identifier: 00191506021467
• UDI-Public: (01)00191506021467(17)260715(10)1100547772
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 08/12/2025

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: 07/15/2026
• Device Model Number: 72404456
• Device Catalogue Number: 72404456
• Device Lot Number: 1100547772
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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: RESERVOIR: UPN: 720185-01 / LOT: 1100591942.; RESERVOIR: UPN: 720185-01 / LOT: 1100591942.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male