MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS AMS INFLATABLE PENILE PROSTHESIS

Model Number 15 CM PROSTHESIS, REAR-TIP CONE EXTENDERS 12 X 14 X 4 CM, PUMP, AND 100 ML RESE

Device Problem Device Inoperable (1663)

Patient Problem Pain (1994)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

Patient had surgery this month for removal of inflatable penile prosthesis that did not work for the patient and caused chronic pain.The ipp had been revised approximately 4 months ago.Surgeon noted in pre-op notes that patient had a lot of problems using the ipp.In the office, the ipp was left partially inflated.Approximately three months after the office visit, the patient reports he could not get the ipp to work at all.It deactivates.He can pump it once, but it does not fill back up.Surgeon questioned whether something is kinked.The surgeon removed the old prosthesis and replaced it with a malleable penile prosthesis.Patient did well post-operatively and was discharged home the day after surgery.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minetonka MN 55343
• MDR Report Key: 5249787
• MDR Text Key: 32145114
• Report Number: 5249787
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 15 CM PROSTHESIS, REAR-TIP CONE EXTENDERS 12 X 14 X 4 CM, PUMP, AND 100 ML RESE
• Other Device ID Number: LOG436500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 58 YR
• Patient Weight: 64