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

Model Number	72404452
Medical Device Problem Codes	Defective Device (2588); Human-Device Interface Problem (2949); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not provided.Therefore, 05/01/2025 was used as approximate date of event.Concomitant product udi for reservoir is (b)94).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) stated that the pump bulb is extremely firm, and he is unable to compress it.During an activation/pump training, the nurse practitioner was unable to inflate it and stated that it was very hard.The patient was told to keep attempting but has no had success.The patient stated that he did inflate it once and left it erect and noticed that it eventually auto deflated.The patient was suggested to make another appointment for device evaluation or pump training.No patient complications were reported.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) stated that the pump bulb is extremely firm, and he is unable to compress it.During an activation/pump training, the nurse practitioner was unable to inflate it and stated that it was very hard.The patient was told to keep attempting but has no had success.The patient stated that he did inflate it once and left it erect and noticed that it eventually auto deflated.The patient was suggested to make another appointment for device evaluation or pump training.No patient complications were reported.
Additional Manufacturer Narrative
Event date was not provided.Therefore, 05/01/2025 was used as approximate date of event.Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Device operates differently than expected and spontaneous deflation are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 22303483
• Report Number: 2124215-2025-40730
• Device Sequence Number: 15458006
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)260827(10)1100578327
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/27/2026
• Device Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100578327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 06/21/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 08/27/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0144-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720185-01 / LOT: 1100583277; RESERVOIR: UPN: 720185-01 / LOT: 1100583277
• Patient Age: 59 YR
• Patient Sex: Unknown