BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1984154 · Received February 10, 2011

    Report

    Report Number
    3005992282-2011-00041
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): BIOLOGICAL DEBRIS THE VELOCITY PORT AND THE LOCKING CONNECTOR WERE RETURNED. THE PORT WAS RETURNED WITH ACTUATOR RING IN THE UNLOCKED POSITION, AND THE EXTREMITY OF HOOKS WAS OUT. ELEVEN (11) PUNCTURES WERE OBSERVED ON THE SEPTUM. THE LOCKING CONNECTOR WAS NOT CONNECTED TO THE PORT. FUNCTIONAL TEST WERE PERFORMED AND PASSED THE FUNCTIONAL TEST. MECHANICAL TEST WERE PERFORMED AND THE HOOKS COULD NOT BE RETRACTED MANUALLY. THE ACTUATOR RING COULD NOT BE ROTATED. USING A SAMPLE PORT APPLIER, THE ACTUATOR RING WAS ROTATED TO THE LOCKED POSITION AND HOOKS DEPLOYED AND ATTACHED TO THE SAMPLE TISSUE MATERIAL BUT WITH DIFFICULTY. THE ACTUATOR RING WAS ROTATED TO THE UNLOCKED POSITION WITH DIFFICULTY AND HOOKS WERE NOT RETRACTED CORRECTLY. THE PORT WAS DISMANTLED AND THERE WERE NO DAMAGED COMPONENTS OBSERVED. BIOLOGICAL DEBRIS WAS OBSERVED IN THE PORT MECHANISM. THE PORT WAS CLEANED AND REASSEMBLED. IT THEN WORKED AS INTENDED. THE ROOT CAUSE OF THIS RESISTANCE WAS FOUND TO BE TISSUE IN -GROWTH, WHICH OCCURRED DURING THE IMPLANTATION PERIOD. IT IS UNLIKELY THAT THIS IS THE ROOT CAUSE OF THE INITIAL PORT FLIP. A DHR REVIEW WAS CONDUCTED A NO NON CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS RELEVANT TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A REALIZE ADJUSTABLE BAND, THE PATIENT HAD TWO PORT REVISIONS. THE FIRST REVISION WAS DUE TO A PORT WAS FLIP. THE PORT WAS REPOSITIONED USING A KELLY ON (B)(6) 2010. ON (B)(6), 2011 A SECOND REVISION WAS NECESSARY. WHEN THEY WENT TO TEST THE PORT, THEY COULD PUSH THE SALINE THROUGH THE PORT INTO THE TUBING BUT COULD NOT WITHDRAW IT. IT WAS FOUND THAT THE LOCKING MECHANISM FOR THE HOOKS WAS NOT SETTING PROPERLY. THERE WAS NO LOCK WHEN THEY WENT TO SNAP IT CLOSE. IT WAS NOT SNAPPING CLOSE THUS ALLOWING THE PORT TO RELEASE AND FLIP OVER. THE PORT WAS REMOVED AND REPLACED ON (B)(6), 2011. THE PATIENT IS OKAY.

    Description of Event or Problem · 1

    CONTACT BY THE PATIENT REPORTING THAT DURING THE FIRST REVISION PROCEDURE , IN ADDITION TO THE PORT BEING DETACHED FROM THE MUSCLE IT WAS ALSO DETACHED FROM THE TUBING AND THAT THERE WAS NO LIQUID IN MY BAND. THE TUBING WAS IN MY ABDOMEN CAVITY. THE PORT WAS RECONNECTED AND APPROXIMATELY 3 OR 4 CCS WERE ADDED. THERE WAS NO ADVERSE IMPACT. ACCORDING TO THE PATIENT THE BAND IS WORKING WELL AND SHE HAS ACHIEVED HER "SWEET SPOT".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1