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	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event entered is an estimated date as the exact date of event was not provided.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) device is going to be revised on a future date due to unspecified reasons.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be implanted in approximately three months.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be implanted in approximately three months.
Additional Manufacturer Narrative
Device evaluation: the spectra cylinders were visually and functionally tested; no damage was found.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.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.

• 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: 10906302
• Report Number: 2183959-2020-05625
• Device Sequence Number: 19554474
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Report Date (Section B): 01/04/2021

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: 02/01/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000226090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 12/15/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/04/2020; 01/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR