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

Model Number	720074-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling/ Edema (4577)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was enrolled in the it matters study on (b)(6) 2024 and had a spectra penile prosthesis (spp) implanted on (b)(6) 2024.The patient developed scrotal cellulitis 28 days following the implant procedure.The patient required hospitalization and antibiotics to manage the condition for four days.There were no device issues noted.The patient has a follow up appointment scheduled for evaluation.There were no additional patient complications.
Event or Problem Description
It was reported that the patient was enrolled in the it matters study on (b)(6) 2024 and had a spectra penile prosthesis (spp) implanted on (b)(6) 2024.The patient developed scrotal cellulitis 28 days following the implant procedure.The patient required hospitalization and antibiotics to manage the condition for four days.There were no device issues noted.The patient has a follow up appointment scheduled for evaluation.There were no additional patient complications.Additional information reported that at the patient's six month follow up, he was using his prosthesis less often than desired.The patient stated he has a loss of sensation due to prior complications with other devices and procedures.He also has a history of stroke.
Event or Problem Description
It was reported that the patient was enrolled in the it matters study on (b)(6) 2024 and had a spectra penile prosthesis (spp) implanted on (b)(6) 2024.Another penile prosthesis was removed also.The patient developed scrotal cellulitis 28 days following the implant procedure.The patient required hospitalization and antibiotics to manage the condition for four days.There were no device issues noted.The patient has a follow up appointment scheduled for evaluation.There were no additional patient complications.Additional information reported that the patient had a jp drain placed for an extended period of time and following the removal of the drain, the patient had a bleeding episode that resulted in swelling and bruising of the phallus.On (b)(6) 2024, the patient had a follow up appointment with scrotal swelling, redness and pain around the incision.The patient started antibiotics and antifungal.The patient was admitted to the hospital and was treated with broad antibiotic coverage for skin and soft tissue infection.The patient developed a hematoma/draining seroma which was thought to be related to the scrotal cellulitis.The patient improved and did not require surgical intervention.Additional information reported that at the patient's six month follow up, he was using his prosthesis less often than desired.The patient stated he has a loss of sensation due to prior complications with other devices and procedures.He also has a history of stroke.
Event or Problem Description
It was reported that the patient was enrolled in the it matters study on april 29, 2024 and had a spectra penile prosthesis (spp) implanted on (b)(6) 2024.Another penile prosthesis was removed also.The patient developed scrotal cellulitis 28 days following the implant procedure.The patient required hospitalization and antibiotics to manage the condition for four days.There were no device issues noted.The patient has a follow up appointment scheduled for evaluation.There were no additional patient complications.Additional information reported that the patient had a jp drain placed for an extended period of time and following the removal of the drain, the patient had a bleeding episode that resulted in swelling and bruising of the phallus.On (b)(6) 2024, the patient had afollow up appointment with scrotal swelling, redness and pain around the incision.The patient started antibiotics and antifungal.The patient was admitted to the hospital and was treated with broad antibiotic coverage for skin and soft tissue infection.The patient developed a hematoma/draining seroma which was thought to be related to the scrotal cellulitis.The patient improved and did not require surgical intervention.Additional information reported that at the patient's six month follow up, he was using his prosthesis less often than desired.The patient stated he has a loss of sensation due to prior complications with other devices and procedures.He also has a history of stroke.

• Brand Name: SPECTRA
• 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: 20709344
• Report Number: 2124215-2024-72362
• Device Sequence Number: 8211536
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• 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: 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,Followup
• Report Date (Section B): 03/06/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 12/02/2024; 02/28/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/03/2024; 03/06/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male