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

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  Injury  

Event Description

It was reported that the patient is requesting a revision of a spectra penile prosthesis(spp) device due to an articulated prosthesis.The patient had surgery between 2010-2014.A patient outcome of stable was reported.

Manufacturer Narrative

Additional information received states the spp device was explanted and a new 14mm x 20cm spp device was implanted on (b)(6) 2019.

Event Description

It was reported that the patient is requesting a revision of a spectra penile prosthesis(spp) device due to an articulated prosthesis.The patient had surgery between 2010-2014.A patient outcome of stable was reported.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8978039
• MDR Text Key: 157152171
• Report Number: 2183959-2019-66074
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other