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

Model Number	720054-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to inflammation with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to inflammation and pain with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.
Additional Manufacturer Narrative
Product analysis was unable to confirm the reported events.The spectra cylinders were visually and functionally tested.Cylinder 1 has sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage and it will be considered a secondary failure.Both cylinders were functionally tested and passed the bend test with a force readout of less than 1390 grams.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported events.A labeling review confirmed that inflammation and pain are both noted as potential adverse events.Therefore, the evaluation conclusion code of known inherent risk of device was assigned to this event.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to inflammation and pain near the genitals with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to inflammation and pain near the genitals with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.

• 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: 10824652
• Report Number: 2183959-2020-05433
• Device Sequence Number: 2988457
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/15/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/19/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000278662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 11/16/2020; 12/08/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 11/16/2020; 11/24/2020; 12/16/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR