BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1881983 · Received October 12, 2010

    Report

    Report Number
    2024601-2010-00823
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE RPTR OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFORM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFO FROM THE RPTR HAS BEEN REQUESTED. 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 REPORTED EVENT OF PAIN AND DEHYDRATION AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ¿ABDOMINAL PAIN, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND¿PORT SITE PAIN."

    Description of Event or Problem · 1

    ALLERGAN RECEIVED A MEDWATCH REPORT STATING: "THE PT HAD AN AP STANDARD ALLERGAN BAND PLACED THREE MONTHS AGO WITHOUT COMPLICATION. THE PT BEGAN REPORTING ABDOMINAL DISCOMFORT NEAR THE PORT SITE TO HER PHYSICIAN A WEEK LATER. THE ABDOMINAL DISCOMFORT INCREASED OVER THE NEXT TWO WEEKS AND BECAME A "CRAMPING, STICKING TYPE PAIN" IN THE LEFT MID-ABDOMINAL REGION THAT CHANGED WITH MOVEMENT, DEEP BREATH, ETCETERA. A CT OF THE ABDOMINAL CAVITY REVEALED THE TUBING WAS FREE IN THE ABDOMINAL CAVITY AND NOT CONNECTED TO THE BAND END OF THE SYSTEM. THE BAND SYSTEM WAS REPLACED TWO MONTHS AGO WITHOUT INCIDENT WITH A NEW SYSTEM. UPON REMOVAL, THERE WAS A SEPARATION OF THE BAND AND THE TUBING. THIS OCCURRED AT THE PART WHERE THE TUBING GOES TO THE PORT WITH A FRACTURE OF THE BAND APPARENTLY OCCURRING JUST DISTAL TO THE BAND ITSELF. THIS IS AFTER THE TAPERING EFFECT AND THE THICKENED PART OF THE TUBING COMES FROM THE BAND AND TRANSFORMS TO THE REGULAR TUBING GOING TO THE PORT. BOTH THE BAND SIDE AND PORT SIDE WERE JAGGED AND DID NOT APPEAR TO HAVE BEEN CUT. THERE WAS NO INJURY TO THE PT. THE REPORTED STATED: NO, THIS EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. THE REPORTED ALSO STATED: "THE ORIGINAL INTENDED PROCEDURE WAS LAP-BAND SYSTEM IMPLANTATION. THE DEVICE USAGE PROBLEM IS NOT KNOWN. REPORTED STATED THERE IS NO OTHER THERAPIES IN USE ON PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1808525

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR