BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 4172800 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00568
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE PORT WAS NOT EXPLANTED AND THE STATUS OF THE BAND PORTION IS UNK. BASED UPON THE TIME OF IMPLANT "SIX OR SEVEN YEARS AGO" PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. BAND SLIPPAGE, REFLUX, AND "ACCIDENTALLY CUT THE STOMACH" DURING REPAIR SURGERY ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE EVENT AND PRODUCT INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT REPORTED HAVING A LAP-BAND SYSTEM IMPLANTED "FIVE OR SIX YEARS AGO." PT STATED THAT "EIGHT MONTHS" AFTER THE SURGERY, THERE WAS AN ISSUE OF "BAND SLIPPAGE." THE PROBLEM WAS FIRST NOTICED WHEN THE PT "COULD NOT KEEP ANY FOOD DOWN." THE PT EXPLAINED THE PHYSICIAN WENT TO FIX THE "BAND SLIPPAGE." AND "ACCIDENTLY CUT THE STOMACH" WHILE TRYING TO FIX IT. THE PHYSICIAN ENDED UP REMOVING THE BAND PORTION, BUT DID NOT REMOVE THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642947 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LEVOTHYROXINE| "BLOOD PRESSURE PILLS"