MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC AMS LGX700 KIT; INFLATABLE PENILE PROSTHESIS, KIT

Model Number 700 ACC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Pain (1994); Chills (2191)

Event Date 05/09/2016

Event Type  malfunction  

Event Description

Patient who had an inflatable penile prosthesis placed this year had removal of the device and components three months later because of infected ipp (implantable penile prosthesis).One month post-op, patient presented with scrotal cellulitis and received 2 weeks of augmentin.Patient seen in surgeon's office for scrotal incision fluctuance.Patient returned 2 days later with open incision and drained purulent fluid, scrotal redness, firmness, scrotum and suprapubic area pain with symptomatic fever and chills.Wbc count 12,000.Patient was hospitalized and received broad-spectrum iv antibiotics for 72 hours.White count normalized and cellulitis resolved.Patient taken to surgery for salvage, washout with removal of prosthesis and washout and placement of an ams malleable prosthesis.Patient did well post-op and discharged to home in stable condition.The following ams implants were explanted: kit pnl pros 700 acc-log586582, manufacturer american medical systems, lot # 120468004.Pros pnl conceal resvr inhbz log586582, manufacturer american medical systems, lot # 114621013.Pros pnl 700 acc rear 4 cm - log586582, manufacturer american medical systems, lot # 105010022.Pros pnl penscr 15 mm -log586582, manufacturer american medical systems, lot # 108341002.Explants are being shipped to american medical systems for further investigation.

• Brand Name: AMS LGX700 KIT
• Type of Device: INFLATABLE PENILE PROSTHESIS, KIT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 5684566
• MDR Text Key: 46091791
• Report Number: 5684566
• 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: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 700 ACC
• Device Lot Number: 120468004
• Other Device ID Number: LOG586582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Weight: 103