BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 6134870 · Received November 30, 2016

    Report

    Report Number
    3006722112-2016-00329
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    December 15, 2010
    Report Date
    November 2, 2016
    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. MEDWATCH SENT TO THE FDA ON 11/30/2016. THIS EVENT WAS REPORTED BY THE PATIENT. TO DATE, APOLLO HAS BEEN UNABLE TO CONFIRM THE REPORTED EVENTS WITH THE PATIENT'S PHYSICIAN. WITHOUT DEVICE OR DEVICE SERIAL, THE TAPER TYPE IS UNKNOWN. IF RETURNED, VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT 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. NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED. NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/ STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING. REOPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED. 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. PATIENTS WITH BARRETT'S ESOPHAGUS MAY HAVE PROBLEMS ASSOCIATED WITH THEIR ESOPHAGEAL PATHOLOGY THAT COULD COMPROMISE THEIR POST-SURGICAL COURSE. USE OF THE BAND IN THESE PATIENTS SHOULD BE CONSIDERED ON THE BASIS OF EACH PATIENT'S MEDICAL HISTORY AND SEVERITY OF SYMPTOMS.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM WAS REPORTED TO "VOMITS EVERY TIME [PATIENT] EATS AND BECAUSE OF THIS [PATIENT] HAS BEEN DIAGNOSED WITH BARRETT'S ESOPHAGUS AND JUST WANTS THE BAND OUT." DEVICE CURRENTLY REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785726 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention OMEPRAZOLE| REGLAN