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

Model Number	720074-01
Medical Device Problem Codes	Break (1069); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Depression (2361)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was submitted spectra prosthesis implantation on (b)(6) 2019.During dilation, we reached the 14-15 caliber but the most caliber prosthesis available was 12 caliber.The prosthesis is placed in situ but the patient is quite disappointed and dissatisfied as it is complained that the prosthesis does not provide the stiffness.Necessary for satisfactory penetration and relationship.The patient reports shame and post-surgical depression due to the ineffectiveness of the procedure.Additional information received indicated a 14 mm cylinder wasn't available as it was not standard practice to have that specific size in stock.Intervention or a revision surgery has not been scheduled yet.The device function looked god at the time of the implant, but the patient complained that the penis without sustaining and the penis double of the relationship time.During x-ray, it was noted that the device needs to be a 14 mm device because it was broken within the cave's body.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9546773
• Report Number: 2183959-2019-68465
• Device Sequence Number: 2283379
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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: 02/27/2023
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 1000064551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR