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

Model Number	720054-02
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an spectra concealable penile prosthesis (spp) procedure due to the patient experienced pain the next day after surgery.The physician believes that the patient had cross over of the spp.The device was replaced with a tactra without any issues and functioning as designed.The patient had a good outcome with no further complications.No more information available at the moment.Should additional information become available, it will be provided.
Additional Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.Product analysis is unable to confirm the reported allegations of pain, perforation and migration nor relate a device malfunction to these reported allegations.The medical and product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.A crease was identified in cylinder 1; however, product analysis is unable to confirm any relationship with this visual abnormality and the reported events nor the reported events related to pain, perforation and migration.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Event or Problem Description
It was reported that the patient underwent an spectra concealable penile prosthesis (spp) procedure due to the patient experienced pain the next day after surgery.The physician believes that the patient had cross over of the spp.The device was replaced with a tactra without any issues and functioning as designed.The patient had a good outcome with no further complications.

• 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: 9563695
• Report Number: 2183959-2019-68560
• Device Sequence Number: 2600975
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/26/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000297907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR