BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1040004 · Received May 6, 2008

    Report

    Report Number
    2024601-2008-00233
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    September 9, 2007
    Report Date
    April 9, 2008
    Manufacturer
    CORTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE AND SERIAL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PAIN AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING SERIAL NUMBER HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INTOLERANCE UNDER "ADVERSE EVENTS" AS FOLLOWS: "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATION AND ADVERSE EVENTS WITH YOUR PATIENT THE RISK WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES VOMITING UNDER "SERIOUS ADVERSE EVENTS" AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EAT MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    REPORT BY THE PT AS "MY DOCTOR TRIED TO ACCESS THE PORT TO WITHDRAW SALINE, THERE WAS NO SALINE IN THE BAND. I HAD 3 CC PUT IN THE BAND. BECAUSE OF ONGOING PROBLEMS WITH THE BAND, THEY REMOVED IT" THE PATIENT ALSO COMPLAINED OF HAVING PAIN AND VOMITING. ADDITIONAL FOLLOW UP FINDING PER THE DOCTOR REPORTED AS, NO LEAKAGE OR SLIPPAGE WERE NOTED AND BELIEVED THE PT DEVELOPED "INTOLERANCE" TO THE DEVICE, SO HE REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI CORTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention