MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 LGX MS PUMP IZ/PRECONNECTED - INFRAPUBIC; PROSTHESIS, PENIS, INFLATABLE

Model Number 72404257

Device Problems Material Erosion (1214); Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Patient with an implantable penile prosthesis was brought to surgery for explant of the device, without replacement.The right cylinder was eroded.Surgeon removed the rear extender, reservoir, right and left cylinder, and a penile kit.No pus was noted during the surgery.Cultures were obtained for suspected infection and sent to lab for examination.The patient was status post radical prostatectomy followed by placement of a penile implant for erectile dysfunction placed in (b)(6)2012 at this hospital.In 2012 the patient had salvage radiation therapy.Surgeon noted a prosthesis infection in his 2018 documentation.There were no complications post-op and the patient was discharged home in good condition.
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manufacturer response for implantable penile prosthesis, ams (per site reporter).
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ams will investigate the device when they receive it.

• Brand Name: AMS 700 LGX MS PUMP IZ/PRECONNECTED - INFRAPUBIC
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 7864238
• MDR Text Key: 119867050
• Report Number: 7864238
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72404257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 78