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

Model Number	720056-03
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this spectra penile prosthesis (spp) to upgrade to an inflatable penile prosthesis (ipp).The spp was removed and an ipp was then implanted without complication.The explanted spp is expected for return and analysis.A supplemental report will be submitted upon return and completion of analysis.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this spectra penile prosthesis (spp) to upgrade to an inflatable penile prosthesis (ipp).The spp was removed and an ipp was then implanted without complication.The explanted spp was returned and analyzed.
Additional Manufacturer Narrative
Product investigation: the complaint component was returned and analyzed; no malfunction was alleged or reported.The two spectra cylinders were visually inspected and functionally tested.One cylinder performed within specifications.The other cylinder did not pass the bend test.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation to ncep/capa/scar is required.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this spectra penile prosthesis (spp) to upgrade to an inflatable penile prosthesis (ipp).The spp was removed and an ipp was then implanted without complication.The explanted spp was returned and analyzed.

• 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: 8599706
• Report Number: 2183959-2019-62994
• Device Sequence Number: 13953153
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/27/2015
• Device Model Number: 720056-03
• Device Catalogue Number: 720056-03
• Device Lot Number: 682383002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR