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

Model Number	720056-03
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was dissatisfied with the spectra concealable penile prosthesis (spp) length.The spp was removed and replaced with ambicor penile prosthesis.No complications reported in relation to this event.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient was dissatisfied with the spectra concealable penile prosthesis (spp) because the length was too short.The spp was removed and replaced with ambicor penile prosthesis.No further complications were reported in relation to this event.The product was explanted but not expected to be returned.Should additional information be received or the product be returned, a supplemental report will be filed upon completion of product analysis.

• 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: 8222967
• Report Number: 2183959-2018-62054
• Device Sequence Number: 16212405
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 10/04/2021
• Device Model Number: 720056-03
• Device Catalogue Number: 720056-03
• Device Lot Number: 0152185004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR