MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number	720054-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient will have his spectra penile prosthesis revised due to an unspecified reason on a future date.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Correction: additional information received on 03-may-2018 indicated that the complaint was not reportable.
Event or Problem Description
Additional information received on 03-may-2018 indicated that the complaint was not reportable.Information was received that the previous spectra was "too small" and was replaced with a "longer and thicker device." no report is required because device sizing is included in the ifu and operating room manual.If the device is too small it would not contribute to a serious injury and there's no indication of a device malfunction.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS, PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 7486130
• Report Number: 2183959-2018-00057
• Device Sequence Number: 11275895
• Product Code: FAE
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Expiration Date: 04/15/2020
• Device Catalogue Number: 720054-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention