BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 5069191 · Received September 10, 2015

    Report

    Report Number
    3006722112-2015-00348
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    October 28, 2011
    Report Date
    August 12, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. APOLLO RECEIVED THE MAUDE EVENT REPORT (MW5042895) FROM FDA ON 08/12/2015. THIS REPORT HAS NO CONTACT INFORMATION FOR FURTHER FOLLOW-UP, AND THEREFORE APOLLO IS UNABLE TO REQUEST THE PRODUCT BE RETURNED, SERIAL NUMBER, OR CLARIFICATION OF EVENTS ASSOCIATED WITH THIS REPORT. DEVICE LABELING: 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. CAUTION: PATIENTS SHOULD BE ADVISED THAT THE LAPBAND® SYSTEM IS A LONG-TERM IMPLANT. EXPLANT 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. CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PATIENT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT.

    Description of Event or Problem · 1

    REPORTED VIA MAUDE EVENT REPORT (MW 5042895) AS: "I HAD THE GASTRIC LAP-BAND PLACED IN 2009. I HAD TO GET IT SURGICALLY REMOVED BECAUSE IT CAUSED SO MUCH PAIN, VOMITING, AND OVERALL SEVERAL HEALTH ISSUES. I DIDN'T LOSE ANY WEIGHT, EVEN THOUGH I WAS COMPLIANT WITH THE DEVICE. IT CAUSED ME TO HOSPITALIZED FOR OVER 2 WEEKS PRIOR TO BEING REMOVED. WORST DECISION OF MY LIFE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598207 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R