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

Model Number	720074-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced several infections with a spectra implant.The old implanted device was removed and a new one was implanted.A patient outcome was not reported.Further information has been requested and is not yet available.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced several infections with a spectra implant.The old implanted device was removed and a new one was implanted.A patient outcome was not reported.Further information has been requested and is not yet available.Should additional information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information received that the physician did not report the cause of the infection because he thinks that the probable cause was the oversize implant.The implant was removed from the patient.The device was originally implanted in 2015.The implant was removed a few months after the original procedure and was not reported or shipped.

• 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: 8500425
• Report Number: 2183959-2019-62152
• Device Sequence Number: 19303858
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 09/18/2023
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 1000165784
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other