MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number	720056-03
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	01/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was enrolled in the it matters clinical study and implanted with a spectra penile prosthesis on (b)(6) 2023.The patient presented a month later with right sided, deep pelvic pain related to an incorrect size of the device.There has been no surgical intervention performed, but the patient was prescribed medication.There were no additional patient complications reported.
Additional Manufacturer Narrative
Updated b5 describe event, h6 patient codes, and h6 evaluation conclusion codes.
Event or Problem Description
It was reported that the patient was enrolled in the it matters clinical study and implanted with a spectra penile prosthesis on (b)(6) 2023.The patient presented a month later with right sided, deep pelvic pain related to an undersized cylinder due to floppy glans.There has been no surgical intervention performed, but the patient was prescribed medication.There were no additional patient complications reported.
Additional Manufacturer Narrative
Updated b5 describe event, b2 outcomes attributed to adv event, d6b explant date h6 impact codes, and h6 evaluation conclusion codes.
Event or Problem Description
It was reported that the patient was enrolled in the it matters clinical study and implanted with a spectra penile prosthesis on (b)(6) 2023.The patient presented a month later with right sided, deep perineum pain that occurred when the implant was moved to the left, as well as localized pain to the ischial tuberosities.The patient was prescribed medication.The patient also experienced difficulty concealing the erection.A couple months later, the patient presented with floppy glans that the physician suspected was related to an undersized cylinder.Approximately a year later, the device was explanted and replaced with longer cylinders.Upon explant, the physician found the right distal cylinder had migrated.Shortly after the procedure, the right cylinder still demonstrated right lateral displacement and a penoplasty was performed.There were no additional patient complications reported.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• 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: 19874647
• Report Number: 2124215-2024-47368
• Device Sequence Number: 7253826
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 03/24/2025

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 Model Number: 720056-03
• Device Catalogue Number: 720056-03
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 03/11/2025
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 08/22/2024; 03/24/2025
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male