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

Model Number	720074-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 6 months of implantation, the patient complained that the prosthesis was not able to support the penis during sexual intercourse, happening to give in laterally (collapsing), making him unable to have intercourse.The patient is dissatisfied and requesting a revision surgery.
Event or Problem Description
It was reported that after 6 months of implantation, the patient complained that the prosthesis was not able to support the penis during sexual intercourse, happening to give in laterally (collapsing), making him unable to have intercourse.The patient is dissatisfied and requesting a revision surgery.The patient had the ams spectra concealable penile prosthesis (spp) replaced as the patient had penile pain and the prosthesis was collapsing on its own axis.
Additional Manufacturer Narrative
Mfr report number 2124215--2021-20035 was determined by the manufacturer to be a duplicate report to this mdr 2183959-2020-05063.Investigation summary: based on the information available, the cause that contributed to the reported device mechanical issue and pain could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of device mechanical issue cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10738005
• Report Number: 2183959-2020-05063
• Device Sequence Number: 3345951
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 05/24/2021
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 0138250003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR