BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZINGER LIGHT SUPPORT 180CM

    MDR report key: 1874214 · Received October 15, 2010

    Report

    Report Number
    1220452-2010-00068
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    February 25, 2008
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQX
    PMA / PMN Number
    K983927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS UNK AND THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. IF IN THE FUTURE ANY ADDITIONAL INFO OR A PRODUCT SAMPLE ARRIVES A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. DEVICE DISCARDED - NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING A PROCEDURE WHILE THE GUIDE WIRE WAS INSERTED INTO THE PT A DISSECTION WAS NOTED. ON (B)(6) 2008, THE PT EXPERIENCED A HEART ATTACK AT HIS HOME AND WAS ADMITTED TO (B)(6) HOSPITAL IN (B)(6). ON (B)(6) 2008, THE PT WAS TRANSFERRED TO (B)(6) FOR THE PURPOSES OF A HEART CATHETERIZATION AND ANGIOPLASTY. AT THE TIME OF THE PT'S ADMISSION, THE PTS NEUROLOGICAL ASSESSMENT WAS WITHIN NORMAL LIMITS. ON (B)(6) 2008, THE PT UNDERWENT A PERCUTANEOUS CORONARY ANGIOPLASTY OF THE RIGHT CORONARY ARTERY. DURING THE COURSE OF THE PERFORMANCE OF THE ANGIOPLASTY, A GUIDE WIRE WAS USED. THE GUIDE CATHETER BECAME DISLODGED, RESULTING IN A RECOIL OF THE GUIDE WIRE. DURING THE COURSE OF THE PROCEDURE, A DISSECTION OF THE RIGHT CORONARY ARTERY WAS NOTICED AFTER BALLOON INFLATION. THE PT UNDERWENT EMERGENCY CORONARY ARTERY BYPASS SURGERY ON (B)(6) 2008. THE PT WAS REINTUBATED AND SUBSEQUENTLY DEVELOPED RENAL FAILURE, A HYPOXIC INSULT, BLINDNESS AND OTHER COMPLICATIONS. SUBSEQUENT THERETO, THE PT ALSO SUFFERED PULMONARY FAILURE. AN ATTEMPT TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZINGER LIGHT SUPPORT 180CM DQX MEDTRONIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention