BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1435144 · Received August 6, 2009

    Report

    Report Number
    3005992282-2009-00225
    Event Type
    Injury
    Date Received
    August 6, 2009
    Report Date
    July 20, 2009
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THEY IMPLANTED A BAND SEVEN MONTHS AGO AND DECIDED NOT TO DO A PLICATION (THOUGHT WILL BE A DIFFICULT ONE WITH HIGH RISK OF "TENSION"). THE PT LOST 70 LBS (25% EWL) NOW WITH A BMI 54. AN X-RAYS/FLURO THREE MONTHS POST-OP WAS TAKEN. MONTHLY FLUORO EXAMINATION SHOWED THE BAND TO BE IN PERFECT POSITION. IN 2009, THE PT PRESENTED WITH SEVERE VOMITING THAT WORSEN TO THE POINT THAT SHE WAS COMPLETELY OBSTRUCTED. ALL THE FLUID WAS REMOVED FROM THE BAND AND FLUORO REVEALED A BIG ANTERIOR PROLAPSE WITH PERSISTENT OBSTRUCTION. THE PT WAS TAKEN TO SURGERY, AND THE BAND WAS REPOSITIONED. IT WAS THE EASIEST SLIPPAGE CASE I EVER HAD, BUT IT WAS PRETTY BIG AND TENSE. LIVER WAS SMALLER. NO ADHESIONS AT ALL. ABLE TO UNLOCK THE BAND, REDUCE THE PROLAPSED STOMACH, CLOSED AGAIN. PLICATED LIKE USUAL. PT DID VERY WELL POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention