BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3130223 · Received May 22, 2013

    Report

    Report Number
    2024601-2013-00410
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    April 26, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURNED THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER OF THE DEVICE AND CLARIFICATION OF THE REPORTED EVENT HAS BEEN REQUESTED. AT THIS TIME, IT IS ASSUMED THAT THE REPORTER IMPLICATED A LEAKAGE FROM THE DEVICE, BASED ON THE ALLEGED MALFUNCTIONING RIGHT AT THE CONNECTION POINT OF THE PORT AND THE TUBING." DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: "THE LAP-BAND AP SYSTEM IS NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL IN WHOLE OR IN PART AT ANY TIME AFTER IMPLANTATION AND NOTWITHSTANDING THE ABSENCE OF ANY DEFECT." 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. CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE. CARE MUST BE TAKEN DURING BAND ADJUSTMENT TO AVOID PUNCTURING THE TUBING WHICH CONNECTS THE ACCESS PORT AND BAND, AS THIS WILL CAUSE LEAKAGE AND DEFLATION OF THE INFLATABLE SECTION."

    Description of Event or Problem · 1

    RISK MANAGER AT USER FACILITY (HOSPITAL) REPORTED TO FDA: "DYSFUNCTIONAL LAP BAND WITH TUBING MALFUNCTIONING RIGHT AT THE CONNECTION POINT OF THE PORT AND THE TUBING. REASON FOR USE: MORBID OBESITY". AT THIS TIME, IT IS ASSUMED THAT THE REPORTER IMPLICATED A LEAKAGE FROM THE DEVICE, BASED ON THE ALLEGED MALFUNCTIONING RIGHT AT THE CONNECTION POINT OF THE PORT AND THE TUBING." FOLLOW UP IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226445 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI