MAUDE Adverse Event Report: LAP-BAND

Device Problem Device Slipped (1584)

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Tissue Damage (2104); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 04/09/2014

Event Type  Injury  

Event Description

I had my lap-band placed in 2008.I was told when having my band placed that the risk of side effects were very minimal, and the band would become a permanent fixture of my life.Since having my band place i have suffered severe gerd, nausea, vomiting, little weight loss due to being forced into eating to little resulting into my body going into starvation mode.My band which only had a so called 1 percent chance of slipping has slipped and now must be removed.It will be removed within the next month and i was advised by the surgeon that there is a likely hood that i will have forever damage done to my stomach and esophagus.I will more then likely have gerd for the rest of my life requiring medication and sleeping at an elevated position to prevent aspirating my own vomit.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• MDR Report Key: 3756905
• MDR Text Key: 4416277
• Report Number: MW5035649
• Device Sequence Number: 1
• Product Code: LTI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 108