MAUDE Adverse Event Report: REALIZE LAPBAND

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Pyrosis/Heartburn (1883); Internal Organ Perforation (1987); Peritonitis (2252)

Event Date 07/25/2014

Event Type  Injury  

Event Description

I had a lapband implanted in 2007.On (b)(6) 2014, after experiencing increasing reflux and mild abdominal pain, i had the device removed.During removal, it was found that the band had eroded into my stomach causing two holes, which were surgically repaired.What was supposed to have been an outpatient procedure became an inpatient admission.Had the device not been removed then, i would have developed peritonitis, which is life-threatening.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): REALIZE
• MDR Report Key: 3979928
• MDR Text Key: 4747585
• Report Number: MW5037584
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 111