BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1802958 · Received August 17, 2010

    Report

    Report Number
    2182208-2010-00578
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 1, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AORTIC VALVE AND ARCH REPLACEMENT, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. A TEMPORARY PACING LEAD WAS IMPLANTED AND FUNCTIONED WELL. TWO DAYS POST-IMPLANT, DUE TO LACK OF STIMULATION BY THE EXTERNAL PACEMAKER, THE PATIENT EXPERIENCED CARDIAC ARREST AND RECEIVED CPR FOR 45 MINUTES WITH EXTERNAL SHOCKS AND IMPLANTATION OF A LEFT VENTRICULAR SUPPORT PUMP. ON THE 6TH DAY POST-OP, A PERMANENT PACEMAKER WAS IMPLANTED. PART OF THE TEMPORARY PACING LEAD REMAINED EMBEDDED IN THE HEART TISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC, INC. 5348 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention