MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. PENILE IMPLANT

Model Number LGX, RESERVOIR, RTE

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Date 08/22/2017

Event Type  Injury  

Event Description

Penile no longer works.Stopped working early july 2017.Air in the device, does not inflate.Device placed november 2012.

• Brand Name: PENILE IMPLANT
• Type of Device: PENILE IMPLANT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. ; minnetonka MN 55343
• MDR Report Key: 6857546
• MDR Text Key: 85904664
• Report Number: MW5072081
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LGX, RESERVOIR, RTE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 103