MAUDE Adverse Event Report: RESHAPE LIFESCIENCES REALIZE BAND; ADJUSTABLE GASTRIC BAND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Regurgitation (2259)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device serial number nor any further device information has been received by apollo.Without the device or device serial number, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.A review of the device labeling noted the following: adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.

Event Description

Reported as: a patient with the lap-band system was reported to have "had some issues with [their] lap-band." device was removed due to reflux.

Event Description

Additional information provided from the physician's office: follow up indicated this is a realize band.There is no complaint against the lap-band.

• Brand Name: REALIZE BAND
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 8688518
• MDR Text Key: 147642625
• Report Number: 3013508647-2019-00032
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention