BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-CLIP ABDOMINAL CLIP

    MDR report key: 1321180 · Received February 19, 2009

    Report

    Report Number
    2135394-2009-00002
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    February 2, 2007
    Report Date
    February 19, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FZP
    PMA / PMN Number
    K031323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, EVALUATION OF THIS DEVICE COULD NOT BE PERFORMED. RESULTS: THE LOT NUMBER FOR THIS DEVICE WAS NOT ABLE TO BE OBTAINED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THUS, ANALYSIS AND DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: BASED ON THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS - THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER COULD NOT BE OBTAINED AT THE TIME OF THIS REPORT. THUS, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN REQUESTED. THERE ARE NO TRENDS RELATED TO THIS ISSUE. THE PATIENT HAS RECOVERED FROM THE PROCEDURE(S). MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S HUSBAND. IN 2007, THE PATIENT'S WIFE UNDERWENT A SUCCESSFUL LAP BAND PROCEDURE. FOUR DAYS LATER, AFTER EATING A MEAL, THE PATIENT HAD SEVERE ABDOMINAL PAIN. A CT SCAN WAS PERFORMED WHICH IDENTIFIED ONE OF THE U-CLIPS OPENED UP, RESULTING IN THE STOMACH PERFORATION. ATTEMPTS TO REPAIR THE PERFORATION LAPROSCOPICALLY WAS UNSUCCESSFUL. ROUTINE SURGICAL PROCEDURE WAS THEN PERFORMED TO REPAIR THE PERFORATION, AND AT THAT TIME, THE LAPBAND WAS REMOVED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED FEVER SECONDARY TO A STAFF INFECTION, HIGH WHITE COUNT, RENAL FAILURE AND FELL INTO COMA. EVENTUALLY, THE PATIENT DID FULLY RECOVER FROM THE PROCEDURE. THE U-CLIP WAS NOT RETURNED FOR ANALYSIS. A COPY OF THE CT SCAN WILL BE FORWARDED TO MEDTRONIC FOR REVIEW. ALSO, THE PATIENT'S RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-CLIP ABDOMINAL CLIP ABC FZP MEDTRONIC PERFUSION SYSTEMS B105 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening