MAUDE Adverse Event Report: LAP BAND

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Pain (1994); Paresis (1998)

Event Type  Injury  

Event Description

Lap band has sent me to the hospital crying in pain for over a year.Also diagnosed with gastroparesis when banded, now are under cardiologist care.Unexplained heart problems after having band removed.Chest pain, pressure after drinking or eating anything.Currently on beta blocker.All unexplained.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 7395549
• MDR Text Key: 104471924
• Report Number: MW5076316
• 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: 04/02/2018

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 36 YR
• Patient Weight: 145