BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND

    MDR report key: 3956130 · Received July 24, 2014

    Report

    Report Number
    3005992282-2014-00043
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 1, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REALIZE BAND WAS IMPLANTED ON (B)(6) 2010. SHE WENT HOME AFTER THE IMPLANT AND WAS NAUSEATED THE NEXT DAY. SHE WENT TO THE EMERGENCY ROOM THE NEXT DAY FOR SEVERE DRY HEAVES AND NAUSEA. ZOFRAN WAS ADMINISTERED IV OVERNIGHT AND THEN SHE WAS RELEASED. THE PATIENT HAD A TOTAL OF FOUR FILLS/ADJUSTMENTS BEFORE HAVING THE BAND REMOVED AND HER MAXIMUM FILL WAS 9CC. ALL FILLS/ADJUSTMENTS WERE PERFORMED BY THE NURSE PRACTITIONER EXCEPT THE LAST ONE WHICH WAS PERFORMED BY THE SURGEON. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS RELATED TO THE BAND. THE SURGEON HAD REQUESTED AN UPPER GI APPROXIMATELY 3 WEEKS PRIOR TO THE REMOVAL TO BE PERFORMED AS A CHECK AND NOTED THAT THE POUCH WAS ENLARGED. ALL THE SALINE WAS REMOVED AND FLUOROSCOPY WAS PERFORMED WITH BARIUM. DURING THE TEST, IT WAS NOTED THE BARIUM DID NOT ADVANCE AND THE SURGEON FOUND THE BAND WAS TOO TIGHT. THE BAND WAS SURGICALLY REMOVED ON (B)(6) 2014. THE SURGEON DISCUSSED PERFORMING A GASTRIC SLEEVE, BUT THE PATIENT DECLINED. THE STATUS OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    ATTENDING SURGEON AND EES MEDICAL DIRECTOR CONCLUDED THAT THE POUCH DILATION EXPERIENCED BY THE PATIENT IS A KNOWN RISK THAT CAN RESULT FROM PATIENT OVEREATING AND OTHER FACTORS. IT WAS ALSO CONCLUDED THAT THESE FACTORS ARE NOT RELATED TO ANY BAND DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433876 REALIZE ADJ GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR