Unknown taper.Medwatch sent to the fda on 11/30/2016.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Further information has been requested of the initial reporter regarding: implant date and explant date.To date, no additional information has been received by apollo.Device labeling addresses the possible event of pain and reflux 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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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 ap® 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.
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Taper ii.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 21/feb/2017.A visual examination was performed and determined the connector type to be taper ii.The port septum was noted to be discolored, brown in appearance.Needle marks were noted on the port septum.Scratches were noted on the port and black particles were noted near the port holes.The lap-band was noted to be separated near the belt and the buckle was noted to be separated.An air leak test was not feasible as the band ring was separated near the belt.A fill inspection test was performed on the port, and no blockage was noted.Under microscopic analysis, the band was noted to have surgical end cuts, consistent with removal of the device.Also under microscopic analysis, the end of port and band tubing were noted to have surgical end cuts, also consistent with removal of the device.
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