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

Model Number 72404256

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 06/06/2019

Event Type  malfunction  

Event Description

Patient had inflatable penile prosthesis implanted over 10 years ago, post radical prostatectomy for cancer.Over the last 8-9 months, he noted pain whenever he sat down.Examination revealed the device had migrated out of position.The device was removed and a new one implanted.No signs of infection noted at the time of surgery.The surgeon described in his operative report that the old implant had "ridden up on the right side over the pubic bone.

• Brand Name: AMS 700 LGX MS PUMP
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 8771215
• MDR Text Key: 150405113
• Report Number: 8771215
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72404256
• Device Lot Number: 551475004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Weight: 84