BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1841325 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00736
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    September 21, 2009
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED WITH THE LAP-BAND SYSTEM BY THE RPTR. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. REFLUX IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE RPTR OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER. THE INFO HAS NOT YET BEEN REC'D BY ALLERGAN. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    REC'D A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. IN THE MESSAGE, HEALTH PROFESSIONAL SAID THEY HAVE A LAP-BAND TO RETURN TO ALLERGAN. F/U FINDINGS: PFN WAS SENT TO ALLERGAN WITH BAND. EVENT DESCRIPTION STATES: "BAND EXPLANT." FURTHER FINDINGS STATE, "WAS EXPLANTED DUE TO NOCTURNAL REFLUX. PROBLEM FIRST OBSERVED WHEN PT COME IN, [WITH WEIGHT] UP (B)(6). AFTER BAND LOOSENING DUE TO REFLUX. WAS REPLACED WITH NEW BAND."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention