BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2125156 · Received May 18, 2011

    Report

    Report Number
    2024601-2011-00405
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED ON THE PROBABLE IMPLANT DATE, THE TAPER TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DISPLACEMENT IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY." "MIGRATION OF THE BAND AND/OR TIPPING OF THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE REOPERATION TO REMOVE OR REPOSITION THE DEVICE."

    Description of Event or Problem · 1

    REPORTED EVENT OF DISPLACEMENT 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 5 EVENTS OF "DISPLACEMENT" LISTED AS "MECHANICAL PORT AND TUBING PROBLEMS" THAT INCLUDED BOTH LEAKS AND DISPLACEMENTS. SINCE NO INFO HAS BEEN RECEIVED 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 Required Intervention