MAUDE Adverse Event Report:; GASTRIC IMPLANT OBESITY

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 04/03/2015

Event Type  Injury  

Event Description

Patient developed progressie dysphagia and pain at band port site.Egd revealed lap band penetration into the gastric wall for several centimeters, adjacent to the cardia.

• Type of Device: GASTRIC IMPLANT OBESITY
• MDR Report Key: 4823493
• MDR Text Key: 15585532
• Report Number: 4823493
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2015
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 06/08/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 85