BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEDISH ADJUSTABLE GASTRIC BAND

    MDR report key: 3953300 · Received July 23, 2014

    Report

    Report Number
    3005992282-2014-00042
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 30, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSISSHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.WHICH REALIZE BAND DID THE PATIENT HAVE IMPLANTED? REALIZE IS ALL HE KNOWS.WHAT WAS THE DATE OF IMPLANT? UNKNOWN, HE DID NOT DO THE ORGINAL PROCEDUREWHAT WAS THE EXACT DATE THE BAND WAS EXPLANTED? (B)(6) 2014.IS THERE A LOT NUMBER AVAILABLE? NO.IS THE BAND AVAILABLE TO BE RETURNED FOR EVALUATION? NO.HOW MANY FILLS/ADJUSTMENT HAD THE PATIENT HAD? PATIENT COULD NOT TOLERATED REFILLS, THE BAND WAS EMPTY.WHAT TECHNIQUE WAS USED TO SECURE THE BAND IN POSITION? UNKNOWN.THIS BAND WAS ORGINALLY PLACED BY A SURGEON WHO HAS SINCE MOVED OUT OF STATE. A DIFFERENT SURGEON REMOVED THE BAND. THE PATIENT HAS BEEN IN THE HOSPITAL FOR 5 WEEKS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF THE REALIZE ADJUSTABLE BAND, THE BAND WAS REMOVED. DURING REMOVAL THEY FOUND THAT THE BUCKLE WAS POSTERIOR ON THE STOMACH AND HAD ERODED INTO THE PANCREAS. THIS CAUSED A FISTULA IN PANCREATIC DUCT.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN DISCHARGED HOME FROM THE HOSPITAL. EXACT DISCHARGED DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431282 SWEDISH ADJUSTABLE GASTRIC BAND LTI IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1