MAUDE Adverse Event Report: LAP BAND

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Unspecified Infection (1930); Pain (1994); Vomiting (2144); No Code Available (3191)

Event Date 10/15/2010

Event Type  Injury  

Event Description

I had a lap band device put in (b)(6) 2009.The first year, i used the band as intended and was able to lose 90 lbs.The doctor told me when i got the band that i would be able to have up to 10cc of fluid put in with no issues.I have never been able to get above 3.5.The last true "adjustment" i had ended up in a lung infection due to aspiration in my lungs from the band being too tight.I fainted in the shower during this incident and several times at the hospital.The emergency room doctor told me i had to get the band loosened and maybe it would help.I had enough fluid removed to feel relief and after that experience i was too scared to get another adjustment.Over the past 2 to 3 years, i have had considerable pain in my port area.I was not able to eat most days until after 1pm due to any food "getting stuck." i tried to eat healthier but eating according to the food pyramid caused me considerable pain and a lot of throwing up.I have had several tests over the past year, some which my health insurance has refused to cover.It has been determined that my port has flipped and the doctor is not able to remove the rest of the fluid in my band.I'm still in pain, i have difficulty eating most days and my doctor has agreed that i should probably get the device removed, and i don't know if my insurance will cover the expense.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 6294263
• MDR Text Key: 66398613
• Report Number: MW5067598
• 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: Other
• Type of Report: Initial
• Report Date: 01/30/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: LAP BAND.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 122