BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP LARGE WITH ACCESS PORT I

    MDR report key: 5016154 · Received August 19, 2015

    Report

    Report Number
    3006722112-2015-00297
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 21, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020190
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. DEVICE RETURN HAS BEEN REQUESTED, HAS NOT BEEN RECEIVED BY APOLLO TO DATE. VISUAL EXAMINATION MAY DETERMINE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FOLLOW-UP INFORMATION REGARDING THE CT SCAN HAS BEEN REQUESTED, NO INFORMATION HAS BEEN RECEIVED TO DATE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAK AS FOLLOWS: "UNPLANNED DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTING TUBING." DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTED AS "PATIENT COMPLAINED OF NO RESTRICTION OF THE LAP-BAND. OMNIPAQUE INJECTION SHOWED THERE WAS A HOLE ON THE LAP-BAND. LAP-BAND WAS EXPLANTED." REPORTER DESCRIBED THERE BEING A HOLE BETWEEN THE PORT AND THE CONNECTOR OF THE BAND, REPORTING "IT LOOKS COMPLETELY CUT OFF, ERODED." FURTHER CLARIFICATION CONFIRMED THE ENTIRE SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547292 LAP-BAND AP LARGE WITH ACCESS PORT I ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. AP LARGE NI 10811955020190

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention