BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADKISTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3123869 · Received May 15, 2013

    Report

    Report Number
    2024601-2013-00380
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    October 15, 2012
    Report Date
    April 23, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. INADEQUATE WEIGHT LOSS IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 INADEQUATE WEIGHT LOSS AS FOLLOWS: "CAUTION: INSUFFICIENT WEIGHT LOSS MAY BE A SYMPTOM OF INADEQUATE RESTRICTION (BAND TO LOOSE), POUCH OR ESOPHAGEAL ENLARGEMENT, AND MAY BE ACCOMPANIED BY OTHER SYMPTOMS, SUCH AS HEARTBURN, REGURGITATION OR VOMITING. IF THIS IS THE CASE, INFLATION OF THE BAND WOULD NOT BE APPROPRIATE."

    Description of Event or Problem · 1

    PATIENT REPORTED A LAP-BAND PORT "LEAK" FIRST NOTICED WHEN "I STARTED GAINING WEIGHT, WENT BACK TO GET ANOTHER FILL, AND THAT IS WHEN THE DOCTOR NOTICED IT." HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN CONFIRMED THE LEAK IN THE "TUBING." THE DEVICE REMAINS IMPLANTED AND EXPLANT SURGERY HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214653 LAP-BAND ADKISTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR PHENPERMINE| EDESVENLAFAXINE ER| BIRTH CONTROL| PREVIFEM