BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1924334 · Received December 7, 2010

    Report

    Report Number
    2024601-2010-01001
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BY THE REPORTER. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE PT DATA. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN". "CAUTION: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION."

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AN ACCESS PORT REMOVED AND REPLACED FOR LEAKAGE. FOLLOW-UP FINDINGS: THREE YEARS PREVIOUSLY, THE APL LAP-BAND SYSTEM WAS REPOSITIONED, REASON NOT SPECIFIED. THE ACCESS PORT WAS REMOVED AND REPLACED FOR SUSPECTED INFLAMMATION OR INFECTION OF THE PORT. THIRTEEN DAYS LATER, THE REPLACEMENT PORT AND THE ORIGINAL LAP-BAND SYSTEM WAS REMOVED FOR INFECTION. FOLLOW-UP FINDINGS: THE REPOSITIONING THREE YEARS PREVIOUSLY WAS FOR A BAND SLIPPAGE. THE SURGEON DOES NOT BELIEVE THE INFECTION WAS RELATED TO THE STERILITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1332371

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention