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

Model Number	720074-03
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Nerve Damage (1979); Deformity/ Disfigurement (2360); Insufficient Information (4580)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issues may have been due to a potential measurement error at implant.
Event or Problem Description
It was reported that the patient, enrolled in the it matters clinical study, with this spectra penile prosthesis (spp) has been experiencing an intermittent cold sensation in the penis since the implant procedure.In addition, the patient stated that he feels the device was undersized.No additional information was provided.
Additional Manufacturer Narrative
Additional information updated: b5: describe event/problem.A3a: sex.A3b: gender.B7: other relevant history.D4: model number, lot number, catalog number, expiration date, unique identifier.E1: initial reporter.E2: health professional? e3: occupation.G2: report source.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issues may have been due to a potential measurement error at implant.
Event or Problem Description
It was reported that the patient, enrolled in the it matters clinical study, with this spectra penile prosthesis (spp) experienced an intermittent cold sensation in the penis since the implant procedure.In addition, the patient was dissatisfied with device girth as he feels it was undersized.A revision surgery was scheduled, and no additional patient complications were reported.
Additional Manufacturer Narrative
Additional information updated: b2: outcomes attrib to adv event.B5: describe event/problem.D6b: explant date.H6: impact codes.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issues may have been due to a potential measurement error at implant.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis (spp) presented an intermittent cold sensation in the penis since the implant procedure.In addition, the patient experienced dissatisfaction with device girth as he feels it was undersized.A revision surgery was performed, during which it was confirmed that the device was undersized, leading to cold sensation, thin penis and floppy glans; therefore, the spp was removed and replaced.No additional patient complications were reported.

• 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: 20471482
• Report Number: 2124215-2024-64896
• Device Sequence Number: 7471746
• 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: 2022
• 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): 03/03/2025

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 Expiration Date: 05/11/2025
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 1000427171
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 02/11/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/09/2025; 03/03/2025
• Date Device Manufactured: 05/12/2020
• 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; Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Male