BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 3010320 · Received March 19, 2013

    Report

    Report Number
    3005992282-2013-00029
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. : INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL COMMENTS: WERE SUTURES USED WHEN ANCHORING THE PORT? NO. DOES THE LOCK SYMBOL ON THE ACTUATOR LINED UP WITH THE TUBING CONNECTION ? YES. WAS A PORT APPLIER BEING USED WHEN THE ISSUE OCCURRED? I WAS NOT PRESENT IN THIS CASE BUT HE DID USE THE PORT APPLIER CORRECTLY IN GENERAL. WHAT METHOD WAS BEING USED TO MANIPULATE THE PORT WHEN THE ISSUE OCCURRED? UNKNOWN. WAS THE SALE REP PRESENT DURING THE FIRST SURGERY ? NO. HOW IS THE PATIENT STATUS? PATIENT CURRENTLY HAS NO PORT IN PLACE. WILL BE REPLACED AT A LATER DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT AN ADJUSTABLE GASTRIC BAND ON THE FIRST FILL THE PORT HAD FLIPPED OVER. THE CLIPS WERE NOTED TO BE RETRACTED ON THE PORT. PORT REMOVED AND WOUND CLOSED. REPLACEMENT PORT TO BE RE-IMPLANTED IN THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113785 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZNKBCG

    Patients

    Seq Age Sex Outcome Treatment
    1