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

Model Number	720056-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Perforation (2001); Scarring (2061); Fluid Discharge (2686)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
Event or Problem Description
It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.
Event or Problem Description
It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.
Additional Manufacturer Narrative
H6: patient codes corrected.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
Additional Manufacturer Narrative
H6: patient codes corrected.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
Event or Problem Description
It was reported that the patient's spectra penile prosthesis (spp) was removed due to unknown reason.A new spp was implanted in the right side only.No information about the patient's outcome was provided.Additional information received.The patient presented a small hole with drainage on the lateral aspect of his penis.There was no cylinder in the left side due to scarring in left corporal body.No device malfunction with previous spp.

• 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: 9897112
• Report Number: 2183959-2020-01678
• Device Sequence Number: 2789462
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 07/31/2022
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 0183201005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 04/13/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/01/2020; 04/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR