MAUDE Adverse Event Report: ALLERGAN LAP-BAND; IMPLANT, INTRAGASTRIC

Device Problems Deflation Problem (1149); Material Discolored (1170); Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Nausea (1970)

Event Date 12/04/2014

Event Type  No Answer Provided  

Event Description

Patient presenting with abdominal pain and nausea.She had gastric banding done 4 years ago with revision one year later because the port tubing needed replacement.She states she thinks the band is deflated.She states that for the last year and a half she has had intermittent abdominal pain associated with nausea when eating.Ct scan in ec demonstrates malpositioned gastric band.Required, laparoscopic removal of laparoscopic band and port.Routine findings consistent with pre-operative diagnosis.Existing band was intraluminal and stained.Inflammatory changes surrounding stomach and on liver.

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC
• Manufacturer (Section D): ALLERGAN; 2525 dupont dr.; irvine, CA 92612
• MDR Report Key: 4588778
• MDR Text Key: 5339125
• Report Number: 4588778
• 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: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 81