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

Catalog Number 720054-02

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Discomfort (2330); No Information (3190)

Event Date 11/15/2016

Event Type  Injury  

Event Description

It was reported the patient had his spectra penile prosthesis removed and replaced with an inflatable penile prosthesis due to patient dissatisfaction.No patient complications were reported in relation to this event.

Manufacturer Narrative

The two spectra cylinders were visually inspected and functionally tested.One performed within specifications.One cylinder had a hole in the outer layer that was the result of a sharp instrument that exposed inner segments.This probably occurred during removal.This cylinder is functional.

Event Description

It was reported the patient had his spectra penile prosthesis removed and replaced with an inflatable penile prosthesis due to patient dissatisfaction.No patient complications were reported in relation to this event.Additional information received indicated the patient had discomfort during sexual intercourse and wanted to "upgrade to a better product." 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: 6116362
• MDR Text Key: 60434382
• Report Number: 2183959-2016-00186
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

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: 01/24/2017
• Device Catalogue Number: 720054-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2012
• 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 Age: 70 YR
• Patient Weight: 58