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

Model Number	72404457
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was working but that since it was implanted the pump was riding high.During a clinic visit, the physician attempted to pull down the pump but reported that it seemed as good as it was going to get and that as long as it was working it was not a problem.More recently however, the pump seemed to be even higher to the point where the tubing was now rubbing on their pubic bone.When the patient is sitting, they have pain in their pelvic area, and they also reported that their penis is curved.The patient had peyronies disease and always had a slight curvature.However, they had the curvature fixed at the same time as their ipp implant surgery.The patient explained that the right cylinder was shorter than the left and was causing the penis to lean to the left.Per the patient it felt like the right cylinder was pushing outward through the side.The patient also saw their nurse practitioner (np) who assessed it and was concerned about erosion of the cylinder over time because the skin on the side was very thin, but they were not an ipp specialist.The np ordered a computed axial tomography (cat) scan for (b)(6) 2026, to assess the implant.No additional information was provided.
Additional Manufacturer Narrative
B3: date is unknown, so implant date was entered.Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100857651 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4).

• 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: 50937304
• Report Number: 2124215-2026-51773
• Device Sequence Number: 10749824
• Product Code: JCW
• UDI-Device Identifier: 00191506021474
• UDI-Public: (01)00191506021474(17)271013(10)1100812813
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404457
• Device Catalogue Number: 72404457
• Device Lot Number: 1100812813
• 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: 09/18/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/13/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male