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

Model Number	72404453
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 12/01/2024 was used as estimate, as it was reported that the event occurred in december.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with the pump riding high in the scrotum.Physician stated it may be due to the new location of the reservoir tubing connecting to the tenacio pump.No additional information was provided.
Additional Manufacturer Narrative
Additional information updated: a2: age.A3a: sex.A3b: gender.B1: adverse event/product problem.B2: outcomes attrib to adv event.B3: date of event.B5: describe event/problem.B7: other relevant history.D4: model number, lot number, catalog number, expiration date, unique identifier.C2/d10: concomitant product/therapy.H1: type of reportable event.H6: impact codes.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with the pump riding high in the scrotum, making the component difficult to operate; therefore, a revision surgery was performed to remove the tenacio pump and replace it with a ms pump.The physician stated the migration may be due to the new location of the reservoir tubing connecting to the tenacio pump.No additional information was provided.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with the pump riding high in the scrotum, making the component difficult to operate; therefore, a revision surgery was performed to remove the tenacio pump and replace it with a ms pump.The physician stated the migration may be due to the new location of the reservoir tubing connecting to the tenacio pump.No additional information was provided.
Additional Manufacturer Narrative
This event was previously reported.See mfr.Report #2124215-2024-78313.Further information will be updated with report #2124215-2024-78313.

• 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: 21355867
• Report Number: 2124215-2025-07234
• Device Sequence Number: 8950176
• Product Code: JCW
• UDI-Device Identifier: 00191506021443
• UDI-Public: 00191506021443
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2025

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: 05/31/2026
• Device Model Number: 72404453
• Device Catalogue Number: 72404453
• Device Lot Number: 1100523972
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 11/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/06/2025; 11/10/2025
• Date Device Manufactured: 05/31/2024
• 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; RESERVOIR: UPN: 720185-01
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male