BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2160178 · Received May 18, 2011

    Report

    Report Number
    2024601-2011-00404
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    August 1, 2010
    Report Date
    April 22, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. (B)(4). THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. SINCE ALLERGAN HAS NOT YET REC'D THIS INFO, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE. MULTIPLE REQUESTS FOR FURTHER INFO HAVE BEEN MADE. ALLERGAN HAS REC'D NO RESPONSE FROM THE AUTHORS. ALLERGAN HAS NOT REC'D THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE EVENT OF LEAKAGE AS FOLLOWS: "WHEN ADJUSTING BAND VOLUME, TAKE CARE TO ENSURE THE RADIOGRAPHIC SCREEN IS PERPENDICULAR TO THE NEEDLE SHAFT (THE NEEDLE WILL APPEAR AS A DOT ON THE SCREEN). THIS WILL FACILITATE ADJUSTMENT OF NEEDLE POSITION AS NEEDED WHILE MOVING THROUGH THE TISSUE TO THE PORT." "WHEN ADJUSTING BAND VOLUME ONCE THE SEPTUM IS PUNCTURED, DO NOT TILT OR ROCK THE NEEDLE, AS THIS MAY CAUSE FLUID LEAKAGE OR DAMAGE TO THE SEPTUM."

    Description of Event or Problem · 1

    REPORTED EVENT OF LEAK FROM JOURNAL ARTICLE: "DOES PREGNANCY INCREASE THE NEED FOR REVISIONAL SURGERY AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING?", OBES SURG (2010) DOI 10.1007/S11695-010-0235-7. THIS MEDWATCH REPRESENTS A POSSIBLE FIVE EVENTS OF "LEAK" LISTED AS "MECHANICAL PORT AND TUBING PROBLEMS" IN TABLES 3 AND 4 OF THE ARTICLE THAT INCLUDED BOTH LEAKS AND DISPLACEMENTS. SINCE NO INFO HAS BEEN REC'D AS TO HOW MANY OF EACH, THESE TWO EVENTS HAVE BEEN DIVIDED EVENLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI