BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM ACCESS PORT I KIT

    MDR report key: 2023249 · Received February 15, 2011

    Report

    Report Number
    2024601-2011-00157
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 18, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 3/15/2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INFECTION AND PAIN ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AND DEHYDRATION AS FOLLOWS: "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

    THE PT CALLED TO REPORT THAT THE ACCESS PORT FOR A LAP-BAND DEVICE WAS REPLACED BECAUSE THE PT WAS EXPERIENCING "EXCRUCIATING PAIN" FOR SIX WEEKS AFTER IMPLANT SURGERY. THE PT STATED THAT THE PAIN SUBSIDED AFTER THE DEVICE WAS REMOVED. F/U WITH THE SURGEON'S OFFICE WAS CONDUCTED. F/U FINDINGS: THE SURGEON NOTICED AN OLD HEMATOMA IN THE AREA OF THE PORT. IN ADDITION, THE SURGEON FOUND ADHESIONS "FROM ANOTHER (PRIOR) SURGERY, UNRELATED TO THE LAP-BAND PORT, AND PERFORMED LYSIS TO REMOVE THESE ADHESIONS. THE SURGEON'S POST-OP DIAGNOSIS ALSO INCLUDED A "WOUND INFECTION AT THE PORT SITE." A CAUSE FOR THIS INFECTION WAS NOT DETERMINED, HOWEVER, THE SURGEON BELIEVES IT "MAY BE RELATED TO THE DEVICE." THE DEVICE WAS NOT RETURNED TO ALLERGAN FOR PRODUCT ANALYSIS, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND SYSTEM ACCESS PORT I KIT LTI ALLERGAN NA 1696873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED