MAUDE Adverse Event Report: LAP-BAND ; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Anemia (1706); Headache (1880); Pain (1994); Injury (2348)

Event Date 02/05/2018

Event Type  Injury  

Event Description

Had a barium swallow done by my gastroenterologist to see if there was some growth in my small intestine causing me anemia.Found that my lap band that i had for 11 years had slipped down cutting off my small intestine.Bariatric surgeon said it needed to be removed asap.Had issues with persistent headaches that couldn't be explained after several er visits and many neurologist visits and tests.Had shoulder pain in left shoulder that couldn't be explained after mris, xrays and several visits to doctor.

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 7714400
• MDR Text Key: 114972605
• Report Number: MW5078556
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• 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: 07/22/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 67