It was reported that the patient had laparoscopic surgery on (b)(6) 2011 ¿whereupon she was implanted with a realize gastric band bearing the serial number (b)(4)¿.On (b)(6) 2011 patient ¿felt a whipping sensation inside her as a result of her realize gastric band failure¿.And patient suffered severe and excruciating pain and discomfort caused by the realize gastric band¿s failure for 54 weeks and also required an additional bariatric surgery.¿.
Manufacturer Narrative
(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.