Complainant stated in a social media post that he/she nearly died before the device was explanted and that testing didn't show an abnormal condition (specified in social media post as "closed completely off".In a follow up private social media post, the complainant stated that the band was implanted in 2006 or 2007 and he/she began to have severe reflux and heartburn about 10 years after implantation and had difficulty processing solid foods.Was unable to sleep except sitted upright.Due to these symptoms, the complainant stated that he/she lost 60 pounds over 3 months and was dying.While waiting for insurance approval to remove the band, the symptoms escalated to kidney failure, low potassium, severe dehydration and other unspecified issues.After stabilizing the patient for three days, the band was removed.One year after explanation the complainant reported getting a successful gastric sleeve procedure (except that there has been little weight loss).Complainant stated that had the explant surgery been delayed more than 2 days, he/she was told that he/she might have died.No other relevant information was provided.
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This information was posted on social media and attempts to contact the poster to follow-up or obtain additional information were unsuccessful and thus, the company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided in the post.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided, as is.No information is available regarding the product that was involved, the authenticity of the complainant, or the veracity of the information provided by the complainant.Unable to determine if the complaint is about the lap-band or about another band which was available in the us and phased out at the end of 2016.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the patient responds with more information.No new risks identified; the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.If additional information becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.Reporter stated that the implant occurred in 2006 or 2007, with no exact date specified.Reporter stated having problems about 10 years after implant, with no exact date specified.
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