MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC AMS CX; PROSTHESIS, PENIS, INFLATABLE

Model Number 700 CX

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Patient was admitted with organic erectile dysfunction as a surgical patient for replacement of an inflatable penile prosthesis that had lost fluid and does not function.The original device was placed approximately four years ago at another facility.The original device was placed through a penoscrotal approach.Patient had surgery to explant the malfunctioning device and replace it using an infrapubic approach.The patient was discharged to home on post-op day 2 with no complications.Device was saved by the hospital for investigation by ams.
=
manufacturer response for inflatable penile prosthesis, ams 18 cm cx penile prosthesis (per site reporter).
=
ams rep was present during the removal of the malfunctioning device.Product will be released to ams for investigation of the malfunction.

• Brand Name: AMS CX
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 3788169
• MDR Text Key: 4442103
• Report Number: 3788169
• Device Sequence Number: 1
• Product Code: JCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 700 CX
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 127