MAUDE Adverse Event Report: ALLERGAN / APPOLLO ENDOSURGERY INC. LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Slipped (1584)

Patient Problems Dyspnea (1816); Choking (2464); Abdominal Distention (2601); Constipation (3274)

Event Date 10/07/2016

Event Type  Injury  

Event Description

Gall bladder removal, band slippage, severe acid reflux that have been told can lead to esophageal cancer, since repair i have trouble eating, continued heart issues, and now trouble breathing as band masses with diaphragm.The lap band has been nothing but a nightmare.I cannot eat, yet lose no weight.My stomach is always bloated and have constipation issues.Continue to choke at night and have to sleep elevated to avoid choking on saliva.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APPOLLO ENDOSURGERY INC.
• MDR Report Key: 7428564
• MDR Text Key: 105518999
• Report Number: MW5076481
• 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: 04/11/2018

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 116