MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX? TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404451
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported by the patient that his inflatable penile prosthesis device was activated last week and he received training on how to pump the device.He stated the training was very quick and did not provide adequate information.When pressing the pump bulb it feels very hard when trying to inflate the device.Additionally, the base of his penis hurts.He also stated that when the device is inflated, the erection does not stick straight out and the head of his penis is floppy, making it difficult for penetration.When the device is inflated, it is causing soreness and tenderness, and the patient feels swelling in the scrotum.He is taking pain medications as a result.The patient is going to consult with another physician to get evaluated.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting number.Correction to field h6: device codes.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.Pain, patient problem/ medical problem, swelling, and difficult to inflate are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.The reported patient allegations of pain, patient problem/medical problem and swelling are known risk associated with this device type and indicated as such in the instructions for use.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available, the cause that contributed to the reported event cannot be excluded as a device problem.
Event or Problem Description
It was reported by the patient that his inflatable penile prosthesis (ipp) device was activated last week and he received training on how to pump the device.He stated the training was very quick and did not provide adequate information.When pressing the pump bulb it feels very hard when trying to inflate the device.Additionally, the base of his penis hurts.He also stated that when the device is inflated, the erection does not stick straight out and the head of his penis is floppy, making it difficult for penetration.When the device is inflated, it is causing soreness and tenderness, and the patient feels swelling in the scrotum.He is taking pain medications as a result.The patient is going to consult with another physician to get evaluated.
Additional Manufacturer Narrative
Model number/catalog number:72018501.Serial number: n/a.Batch/lot number:1100693452.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) # :(b)(4).Correction to field b1: adverse event/product problem.Correction to field b2: outcomes attrib to adv event.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.Pain, patient problem/ medical problem, swelling, and difficult to inflate are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.The reported patient allegations of pain, patient problem/medical problem and swelling are known risk associated with this device type and indicated as such in the instructions for use.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available, the cause that contributed to the reported event cannot be excluded as a device problem.
Event or Problem Description
It was reported by the patient that his inflatable penile prosthesis device was activated last week and he received training on how to pump the device.He stated the training was very quick and did not provide adequate information.When pressing the pump bulb it feels very hard when trying to inflate the device.Additionally, the base of his penis hurts.He also stated that when the device is inflated, the erection does not stick straight out and the head of his penis is floppy, making it difficult for penetration.When the device is inflated, it is causing soreness and tenderness, and the patient feels swelling in the scrotum.He is taking pain medications as a result.The patient is going to consult with another physician to get evaluated.

• 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 ; +1(508)652-1217
• MDR Report Key: 22948031
• Report Number: 2124215-2025-60408
• Device Sequence Number: 15705088
• Product Code: JCW
• UDI-Device Identifier: 00191506021429
• UDI-Public: (01)00191506021429(17)261022(10)1100615572
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2026

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 Model Number: 72404451
• Device Catalogue Number: 72404451
• Device Lot Number: 1100615572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 03/11/2026; 07/30/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 02/10/2026; 04/09/2026; 08/06/2026
• Date Device Manufactured: 10/22/2024
• 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 LOT 1100693452, UPN 72018501; RESERVOIR LOT 1100693452, UPN 72018501
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male