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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAPBAND AND REALIZE

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LAPBAND AND REALIZE Back to Search Results
Device Problems Device Inoperable (1663); Malposition of Device (2616)
Patient Problems Diarrhea (1811); Failure of Implant (1924); Tissue Damage (2104); Hernia (2240)
Event Date 09/11/2015
Event Type  Injury  
Event Description
I have been told repeatedly to lose weight by primary practitioner or to avail myself of a weight loss surgery.I did so twice with the two lapband device ports utilized for lapband surgeries.Both times my surgeries were done by the (b)(6) hospital.Both surgeries failed and both time the port flipped over both times.I went repeatedly for port manipulations and fluoroscopy to no avail.I had been left disgusted with the whole turmoil of two surgeries to correct the port position and repeated misadventures of using spinal needles to 'flip' the port over leveraging needles left in place from failed angles of approach whilst piercing my abdomen.The fresh spinal needles to stabilize a obviously poorly positioned surgical intervention of a medical device used for lapband filling.I was both times given excuses for why this happened and why another attempt to secure a port would be needed or given a removal of the port.The advice would be to have a gastric sleeve surgery done to achieve the weight loss that the 'lapland had promised.During the time that the port was in my body, i had diarrhea.The port was never able to be filled but it did have the effect of causing a "dumping" while installed around my upper stomach.I endured this 'problem' for five years and could not stand it anymore.I didn't want to go back to the surgeons that put both the failed ports in , so i went to another hospital group and went through the whole process again of trying to fill the port and have the failure documented, so i could have the port removed.Having never been able to fill the device by yet another group of surgeons.Once the port and the bands removed, the diarrhea stopped.None since surgery successfully removed the port that was non functioning and 'turned over' twice with two lapband surgeries from 'the bridges center' for bariatric surgery in (b)(6) medical center.The surgeons can place the band but they can't fill them and caused successive surgery to remove malfunctioning port and band due to chronic diarrhea and problems with inflammation with a non functioning port.The surgeon removing the nonfunctioning port indicated that they are taking out about fifty percent of the ports they put in."they never worked like they claimed".Why is the fda not "doing something" about the claims of the weight loss center? they shouldn't be allowed to continue putting these ports in, if they can't fill them due to malposition of these ports being able to place the 'band' around the upper stomach which does not ensure weight loss, "if" they can't anchor the access ports.How many people are having the same problem that i had to endure.There were two more surgeries i had to endure to correct this problem of ports flipping over.It is agony trying to fill these failed ports.We are talking using multiple long needles through the skin into the abdomen trying to 'flip' these ports.It took five years to try and summon the courage to have another surgery but was forced to by the chronic diarrhea from the port being there.I was told that there was a "dumping syndrome" from the band being there but it never went away until the band was removed.The (b)(6).I was told 'this never happens' to have two failed ports with the lapband placement but since then, the surgeon for the 'new bariatric group has stated to me."they never worked and we are taking out as many as we are putting in." there is a problem here that you need to intervene with.From what i can gather "they never worked" is not a 'good outcome' for bariatrics so i wonder who is in control here.My ribs were sore the whole time the band was around my upper stomach and there was a hernia occurring where the band and port were inserted.Sore ribs on top of band placement now gone with removal of the band.There were three surgeries with the last removing the 'lapband' in (b)(6) hospital to prepare for a gastric sleeve.
 
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Brand Name
LAPBAND AND REALIZE
Type of Device
LAPBAND
MDR Report Key5204381
MDR Text Key30628586
Report NumberMW5057700
Device Sequence Number2
Product Code LTI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/01/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/01/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention; Disability;
Patient Age385 DA
Patient Weight173
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