BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP STANDARD W/ ACCESS PORT I

    MDR report key: 6061476 · Received October 27, 2016

    Report

    Report Number
    3006722112-2016-00312
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020183
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE DEVICE CURRENTLY REMAINS IMPLANTED. BASED ON THE SERIAL NUMBER PROVIDED, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. IF EXPLANTED AND RETURNED, VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER TAPER TYPE ASSOCIATED WITH THIS EVENT. DEVICE LABELING ADDRESSES THE EVENT OF PAIN, NAUSEA AND VOMITING 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. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND® SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY AND WOUND INFECTION.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE LAP-BAND SYSTEM, WHO IS PART OF THE APOLLO-001 CLINICAL STUDY WAS REPORTED TO HAVE "PAIN, NAUSEA, AND VOMITING." PATIENT WAS HOSPITALIZED FOR THE NAUSEA AND VOMITING. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713390 LAP-BAND AP STANDARD W/ ACCESS PORT I ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. B-2240 2790427 10811955020183

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R ASPIRIN| MULTIPLE MEDS FOR STAGE 2 HYPERTENSION| NON-INSULIN MEDS FOR DIABETES