MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM ACCESS PORT; ADJUSTABLE GASTRIC BAND ACCESS PORT

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This report captures the patient's replacement port that was removed due to port displacement.The patient's lap-band system removal was captured under mdr 3013508647-2019-00026.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Device labeling addresses the reported event as follows: 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.Other adverse events considered related to the lap-band® system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.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 noted the port moved again causing me to have so many issues with fills and needles almost breaking on the port edges.The port was removed.

• Brand Name: LAP-BAND SYSTEM ACCESS PORT
• Type of Device: ADJUSTABLE GASTRIC BAND ACCESS PORT
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: kristin wielenga ; 1001 calle amanecer; san clemente, CA 92673
• MDR Report Key: 8671691
• MDR Text Key: 147090570
• Report Number: 3013508647-2019-00037
• 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
• Report Date: 05/06/2019

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: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OXYCODONE; PRESCRIPTION NEXIUM; TYLENOL
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 80