MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720074-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient is dissatisfied with the spectra penile prosthesis because it is not a rigid and it is inadequate for intercourse.It was indicated that the device does not seem to have any issues, the patient is just dissatisfied with the feel.It was indicated by the patient that "subsequently to this procedure, my sexual performance and ability to reach a climax became almost nonexistent because of the lack of sensitivity and the feeling of penetrating my wife" and "most of a year had pass and mounting psychological trauma, along with the disappointment and frustration of my wife" caused the patient to seek a second opinion.The patient noted that "prior to having this procedure performed.This problem did not exist nowhere near to this extent" and "i strongly believe that this whole ordeal was a major contributing factor to my heart attack which occured on (b)(6) 2015." it was also indicated that the physician "told the patient that a lot of his symptoms that he is having are expected after penile prosthesis implantation.It is also possible that his other disease processes may have some effect on his sexual performance." no additional patient complications were reported in relation to this event.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5367252
• MDR Text Key: 35974862
• Report Number: 2183959-2016-00035
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2018
• Device Catalogue Number: 720074-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 132