BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2896430 · Received December 28, 2012

    Report

    Report Number
    2024601-2012-01345
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    May 31, 2011
    Report Date
    December 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INFECTION AND STOMACH PERFORATION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE 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: "CAUTION: IN REVISION PROCEDURES THE EXISTING STAPLE LINE MAY NEED TO BE PARTIALLY DISRUPTED TO AVOID HAVING A SECOND POINT OF OBSTRUCTION BELOW THE BAND. AS WITH ANY REVISION PROCEDURE, THE POSSIBILITY OF COMPLICATIONS SUCH AS EROSION AND INFECTION IS INCREASED. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN PERITONITIS AND DEATH, OR IN LATE EROSION OF THE DEVICE INTO THE GI TRACT." "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YRS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES SURGICAL TECHNIQUE IN REGARDS TO PERFORATION: "CAUTION: DURING INSERTION OF THE CALIBRATION TUBE, CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE ESOPHAGUS OR STOMACH." "CAUTION: DO NOT PUSH THE TIP OF ANY INSTRUMENT AGAINST THE STOMACH WALL OR USE EXCESSIVE ELECTROCAUTERY. STOMACH PERFORATION OR DAMAGE MAY RESULT. STOMACH PERFORATION MAY RESULT IN PERITONITIS AND DEATH."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO INFECTION. THE RPTR ALSO NOTED A "GASTRIC PERFORATION FROM [LAP-BAND] PLACEMENT WITH INTACT IMBRICATION AND NO ACTIVE LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2100017

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention