BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3250002 · Received July 24, 2013

    Report

    Report Number
    2024601-2013-00628
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE CATALOG NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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 PAIN AND DIARRHEA AS FOLLOWS: WARNINGS: "11, PATIENTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESE SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYSTEM."

    Description of Event or Problem · 1

    PT REPORTED "I WAS WONDERING IF LAP BAND CAN BE THE CAUSE OF MY STOMACH CRAMP PAIN THEN DIARRHEA? I'M JUST TRYING TO RULE THIS OUT BEFORE I THINK IT'S A STOMACH VIRUS." F/U INFO: HEALTHCARE PROFESSIONAL REPORTED, "FROM THE FIRST FILL THERE WAS NO FLUID IN THE BAND ALTHOUGH IT HAD BEEN ADDED." HEALTHCARE PROFESSIONAL NOTED THAT THE PT HAD A REPAIR SURGERY ABOUT 5 MONTHS AFTER IMPLANT SURGERY AS THE DEVICE HAD "FRACTURED OR DISCONNECTED AT A JUNCTION IN THE TUBING." RECENTLY, HEALTHCARE PROFESSIONAL IDENTIFIED ANOTHER TUBING DISCONNECT STATING THE PT "PRESENTS FOR EVAL OF TREATMENT OPTIONS FOR ABDOMINAL PAIN IN THE PELVIC REGION. [PATIENT] HAD SIMILAR PAIN PREVIOUSLY WHEN [THEIR] TUBING WAS DISCONNECTED." NO SURGERY OR TREATMENT HAS BEEN PERFORMED FOR THE REOCCURRENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345423 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2246363

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention